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SurgIcal technIqueSurgIcal technIque

SYnaPSe™ oct SYSteM An enhanced set of instruments and implantsfor posterior stabilization of the upper spine

Image intensifier control

DePuy Synthes Companies SYNAPSE OCT System Surgical Technique

IntroductIon

SurgIcal technIque

IntroductIon

SurgIcal technIque

SYnaPSe™ oct System 2

ao Principles 5

Indications and contraindications 6

Preparation 7

Surgical technique 9

additional techniques 20

Implant removal 29

assembly guide 33

SYnaPSe oct System compatibility Matrix 38 occipital cervical Fusion System 39

Preparation 42

occipital Plate technique 44

occipital Fusion connectors 55

occipital clamp technique 59

occipital Plate/rod technique 68

Implant removal 74

oc Fusion System compatibility Matrix 75

table oF contentS

the DePuy Synthes Spine SYnaPSe™ occipito-cervico-thoracic Fixation System is an enhanced set of instruments and implants, including clamps, top loading variable axis screws, hooks, transconnectors, and transverse bars and rods, designed for posterior stabilization of the upper spine. the implants provide the fl exibility required to accommodate variations in patient anatomy.

the DePuy Synthes Spine SYnaPSe oct System uses 3.5 mm and 4.0 mm rods, allowing components from SYnaPSe System, aXon™ Pedicle Screw System, and DePuy Synthes Spineoccipital cervical Fusion systems to be interchanged. additionally, tapered rods are available to extend DePuy Synthes Spine SYnaPSe oct System constructs to the lower spine using the DePuy Synthes Spine eXPedIuM® Spine System.

System features• 3.5 mm and 4.0 mm titanium* rods• top-loading hooks• Multiple implant options for crossing the

cervicothoracic junction• Fully compatible with the oc Fusion System• Square-threaded locking screws• robust polyaxial screws• top-loading transconnectors

*titanium-6% aluminum-7% niobium alloy

1 DePuy Synthes Companies SYNAPSE OCT System Surgical Technique

dePuY SYntheS SPIne SYnaPSe™ oct SYSteM

DePuy Synthes Companies SYNAPSE OCT System Surgical Technique 3

dePuy Synthes Spine SYnaPSe oct System

Top-loading transconnectors• head-to-head connection for increased stability • adjustable connector available in four variable lengths

to accommodate different patient anatomy• assemble on the head of any SYnaPSe Polyaxial Screw• Straight and angled versions offer enhanced

flexibility options


Robust polyaxial screws• top loading• 4.0 screws accommodate 3.5 mm diameter and

4.0 mm diameter rods• one-piece body• Self-tapping• three diameters with cancellous profi le: – 3.5 mm diameter – 4.0 mm diameter (rescue screw) – 4.5 mm diameter• 3.5 mm diameter and 4.0 mm diameter cancellous screws

offer up to 50° angulation (4.0 mm diameter screws offer up to 40° angulation)

dePuy Synthes Spine SYnaPSe oct System

the threaded driver eliminates driver “sticking” to the bone screw.

Shaft screw• lengths from 18 mm–50 mm* with a 10 mm

unthreaded shaft (2 mm increments)• Self-tapping• Shaft screws with cortical profi le• offers 40° angulation in all directions

*Screw length is total length.

50°

50°

In 1958, the ao formulated four basic principles, which have become the guidelines for internal fixation.1 they are:• anatomic reduction• Stable internal fixation• Preservation of blood supply• early, active mobilization

the fundamental aims of fracture treatment in the limbs and fusion of the spine are the same. a specific goal in the spine is returning as much function as possible to the injured neural elements.1,2

1. Müller Me, allgöwer M, Schneider r, Willenegger h. Manual of Internal Fixation, 3rd edition. berlin: Springer-Verlag; 1991.

2. aebi M, thalgott JS, Webb JK. AO ASIF Principles in Spine Surgery. berlin: Springer-Verlag; 1998.


ao PrIncIPleS

IndIcatIonS the SYnaPSe oct System is indicated as follows:

the Synapse oct System, including Synapse, oc Fusion, and axon, is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (c1 to c7) and the thoracic spine (t1-t3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (eg, pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with intability. the Synapse oct System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the axon and Synapse Systems may be connected to the Synthes universal Spinal System using parallel connectors and tapered rods. the Synapse oct System can also be linked to the titanium dePuy eXPedIuM Spine System using the 3.5 mm/5.5 mm and 4.0 mm/5.5 mm titanium tapered rods.

WarnIngSthis device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the thoracic (t4-t12) or lumbar spine.

cocr rods are not intended to be used with the SYnaPSe System. additionally, cocr tapered rods are not intended to connect the SYnaPSe System to the DePuy eXPedIuM Spine System.

the safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. these conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the l5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). the safety and effectiveness of these devices for any other conditions are unknown.

contraIndIcatIonScontraindications for the use of the SYnaPSe oct System include:• active systemic infection or an infection localized to the site of the

proposed implantation• Severe osteoporosis may prevent adequate fixation of the screws and

preclude the use of this or any other spinal instrumentation system• Patients who have been shown to be safely and predictably treated

without internal fixation• open wounds• Foreign body sensitivity

Mental or physical impairment, which compromises or prevents a patient’s ability to comply with necessary limitations or precautions, may place that patient at a particular risk during postoperative rehabilitation.

Factors such as the patient’s weight, activity level, and adherence to weight- bearing or load-bearing instructions have an effect on the stresses to which the implant is subjected. additional factors which may preclude the possibility of fusion include any underlying physiological conditions such as kidney dialysis, cancer, osteopenia, smoking, or diabetes.

the SYnaPSe oct System (hooks) are contraindicated for use in postlaminectomy cases.

Please refer to package insert for complete labeling.

For detailed cleaning and sterilization instructions of the instruments used with the Synapse oct System, please refer to:www.synthes.com/cleaning-sterilization.


IndIcatIonS and contraIndIcatIonS

PreParatIon

1Preparation

Required set

01.614.001e SYnaPSe Instrument and titanium Implant Set or 01.615.006e SYnaPSe 4.0 mm Instrument and

titanium Implant Set

Optional set

01.601.020e occipital cervical Fusion Instrument and titanium Implant Set

01.601.023e oc Fusion enhancement Set for 3.5 mm rod


01.614.021e SYnaPSe enhancement Instrument Set

01.614.020e 3.5 mm ti curved rod Set for SYnaPSe System

01.615.020e 4.0 mm ti curved rod Set for SYnaPSe System

01.614.001


3Position patient

Patient positioning is critical for cervical posterior fusion procedures. Place the patient on the operating table in the prone position with the patient’s head securely immobilized. Proper patient position should be confirmed via direct visualization prior to draping and by radiograph.

always use caution when positioning the patient, as physiologic alignment may not be attainable.

4Approach

use the standard surgical approach to expose the spinous processes and laminae of the vertebrae to be fused.

2Preoperative planning

all necessary imaging studies should be available to plan implant placement and visualize individual patient anatomy.

use of cross sectional imaging (ie, ct and/or MrI) for posterior cervical screw placement is recommended due to the unique risks in the cervical spine. the use of planar radiographs alone may not provide the necessary imaging to mitigate the risk of improper screw placement. In addition, use of intra-operative imaging should be considered to guide and/or verify device placement, as necessary.

5Assemble instruments

the following instruments must be assembled prior to use:• Screwdriver• Persuader• drill guide• depth gauge

assemble instruments according to the assemblyinstructions found on page 33–37, or refer to www.synthes.com/cleaning-sterilization.

Preparation


2Select screw and drill guide

Instruments

388.394 2.4 mm drill bit with 65 mm stop, quick coupling

388.393 drill guide with graduation, for 2.4 mm drill bit

03.614.010 3.2 mm drill bit with 65 mm stop, quick coupling

03.614.011 drill guide with graduation, for 3.2 mm drill bit

Alternative instruments

03.615.030* turn-to-lock drill guide for 2.4 mm drill bit


Select the drill bit and drill guide that correspond to the screw diameter to be used. the 3.5 mm and 4.0 mm screws have the same core diameter (2.4 mm) and require the use of the same drill bit and drill guide, identified with a yellow band. the 4.5 mm screws have a larger core diameter (3.2 mm) and require the use of the drill bit and drill guide identified with a light blue color band. See table to right.

1Start screw hole

Instrument

388.397 awl

determine the entry point and trajectory for the screw and use the awl to create a pilot hole. this helps to prevent displacement of the drill bit during initial insertion.

Screw Turn-to-Lock Diameter Drill Bit Drill Guide Drill Guide3.5 mm 388.394 388.393 03.615.0304.0 mm 388.394 388.393 03.615.0304.5 mm 03.614.010 03.614.011 03.615.031

*additionally available.


SurgIcal technIque

3Set drill guide depth

Instruments

03.614.011 drill guide with graduation, for 3.2 mm drill bit or 388.393 drill guide with graduation, for 2.4 mm

drill bit

to set the drill guide to the desired depth, slide back the latch to release the inner tube; align the distal end of the internal drill guide tube with the appropriate depth calibration on the window. release the latch to lock the drill guide at the desired depth.

Alternative instrument

389.475* drill guide, 14 mm, for 2.4 mm drill bit

a drill guide with a fixed depth of 14 mm is additionally available for both 3.5 mm and 4.0 mm screws.




Slide inner tube until desired depth aligns with markings. to lock this drill guide, pull back the latch, rotate the tube clockwise, and release the latch.



Surgical technique

4Drill hole

Instruments

388.393 drill guide with graduation, for 2.4 mm drill bit

388.394 2.4 mm drill bit, quick coupling, with 65 mm stop

388.549 Straight ball tip Probe

drill to the desired trajectory and depth, using the 2.4 mm drill bit and drill guide. use the straight ball tip probe to confirm, by palpation, accurate placement within the pedicle.

Caution: Do not touch the latch when drilling. Touching the latch could disengage the lock resulting in uncontrolled depth and potential harm to the patient.


03.614.010 3.2 mm drill bit with 65 mm stop, quick coupling

03.614.011 drill guide with graduation, for 3.2 mm drill bit



Alternative technique

Instruments

03.614.012 Pedicle Probe, 2.4 mm

03.614.013 curved Pedicle Probe, 2.4 mm

Pedicle preparation may also be performed using either the pedicle probe or curved pedicle probe.



Surgical technique

Optional technique

Instruments

389.473 Small Pedicle Marker, beaded

389.474 Small Pedicle Marker, long beaded

the small pedicle markers may be used to radiographically confirm position and orientation of screw sites.

5Measure

Instrument

03.161.028 depth gauge

use the depth gauge to confirm hole depth and select the corresponding screw length. the depth gauge reading and the screw length indicate actual bone purchase. the depth gauge must sit directly on the bone.


Surgical technique

6Insert screw

Instruments

03.614.017 threaded holding Sleeve, for polyaxial screws

03.614.018 cross Pinned StardrIVe™ Screwdriver Shaft, t15, self-retaining, quick coupling

324.107 quick coupling handle, with swivel cap

Optional instruments

03.614.036 Slip Sleeve, for threaded holding Sleeve

03.614.039 cross Pinned hexagonal Screwdriver Shaft, quick coupling

03.614.041* ratchet t-handle with quick coupling

03.688.505* Small ratchet handle with quick coupling

refer to page 33–34 for screwdriver assembly and implant attachment instructions.

Insert the selected 3.5 mm or 4.5 mm self-tapping DePuy Synthes Spine SYnaPSe oct System screw. a 4.0 mm emergency screw may be used if the primary 3.5 mm screw has less than optimal fixation.

Note: The optional slip sleeve may be used to grip the holding sleeve during screw insertion.



Surgical technique


Instruments

03.614.015 tap for 4.5 mm cancellous bone Screws, 205 mm, 50 mm calibration

03.614.016 4.5 mm/3.5 mm tap Sleeve

311.349 tap for 3.5 mm cancellous bone Screws, 50 mm calibration

389.477 tap for 3.5 mm cortex Screws, 50 mm calibration


03.614.052 undersized tap for 3.5 mm cancellous Screws

03.614.053 undersized tap for 4.5 mm cancellous Screws

03.614.045 Short tap for 3.5 mm cancellous bone Screws with sharp tip

03.614.046 Short tap for 4.5 mm cancellous bone Screws with sharp tip

dense bone may be tapped using the appropriate tap, depending on the chosen screw.

the tap sleeve may be used as a tissue protector, and to indicate tap depth.

* undersized taps are 0.5 mm smaller than nominal, eg, the undersized tap for 3.5 mm screws has a diameter of 3.0 mm.

Tap selection guide

undersized* nominal

3.5 mm cancellous Screw 03.614.045 311.34903.614.045

4.0 mm cancellous Screw 311.349 n/a

4.5 mm cancellous Screw 03.614.053 03.614.01503.614.046

3.5 mm cortex Screw n/a 389.477


Surgical technique

7Place additional screws

use the same technique to insert the remaining screws.

8Contour template

Instrument

388.868 rod template, 240 mm (for 3.5 mm and 4.0 mm rods)

contour the rod template to fit the anatomy.


Surgical technique

9Bend and cut rod

Instruments

03.614.021 rod cutter

03.614.022 rod/Plate bender

use the rod/plate bender to contour the rod to match the curve of the template. the bend line arrow indicates where the rod will be bent.

use the rod cutter to cut the rod to the appropriate length.


Shorter rod sections may be bent by placing one end of the rod on the internal ledge of the bending feature.


03.614.024 bending Iron, left

03.614.025 bending Iron, right

the bending irons can also be used as pipe rod benders. Insert the rod into the rear of each bending iron and lock in place by turning the thumbwheels clockwise. With both ends locked inside the irons, the rod may be contoured.

Caution: Repeated bending and notching may weaken rod.

Internal ledge


Surgical technique

10Insert rod

Instrument

388.407 holding Forceps


03.614.024 bending Iron, left

03.614.025 bending Iron, right

03.614.034 alignment tool

03.614.047* rod Pusher/head turner

Insert the rod into the variable axis heads of the screws using the holding forceps. the alignment tool may be used to help orient the heads to the correct position. the bending irons may be used to adjust the curve of the rod.

11Insert locking screw

Instruments

03.614.019 StardrIVe Screwdriver Shaft, t15, self-retaining, quick coupling

03.614.035 2 nm torque limiting handle, with quick coupling

loosely fasten the locking screws using the StardrIVe Screwdriver Shaft with the 2 nm torque limiting handle. When inserting the locking screws, they may be turned one-quarter to one-half turn counterclockwise to seat the thread before tightening.


03.614.050* dual Sided locking cap Inserter

Caution: Not meant to be used for final tightening.



Surgical technique


Instrument

03.614.027 Persuader or 03.615.009 Persuader, for 4.0 mm rods

use the persuader to introduce the titanium rod into the variable axis head of the screw. Place the persuader over the rod and onto the variable axis head so the tip of the persuader sits below the screwhead reduction feature. Squeeze the handle to engage the persuader and introduce the rod into the head of the screw. loosely fasten the locking screws using the StardrIVe Screwdriver Shaft with the 2 nm torque limiting handle through the cannulation of the persuader. When inserting the locking screws, they may be turned one-quarter to one-half turn counterclockwise to seat the thread before tightening.

Optional instrument

03.615.042* locking Persuader handle

If using the locking Persuader handle, squeeze the handle to engage the pursuader and introduce the rod into the head of the screw. thread the nut down to lock reduced position.

Optional technique

Instrument

03.614.023 rod holder

If rotation of the rod is desired, it is recommended that the rod holder be used.



Surgical technique

12Lock construct

Instruments


03.614.026 countertorque or 03.615.010 countertorque, for 4.0 mm rods

03.614.035 2 nm torque limiting handle

after final adjustment of the construct, fully tighten all locking screws with the screwdriver shaft and the 2 nm torque limiting handle. the construct is now rigidly locked. Final tightening should be accomplished after all locking screws have been placed, and should be aided by the countertorque tool.

Note: The persuader may be used in place of the countertorque tool.

Optional technique

Instruments

03.615.016* rocker Fork for 4.0 mm rod

03.614.049* rocker Fork for 3.5 mm rod

Place the open center of the rocker fork onto the top of the rod, with the feet below the screw side notches. lever the fork back until the rocker fork engages the side notches of the screw. In a slow and controlled way, lever the fork until the rod is seated into the polyaxial head.



Surgical technique

13Apply compression or distraction

Instruments

03.614.028 distraction Forceps

03.614.029 compression Forceps

compression or distraction with variable axis heads is only possible if the locking screws have not been tightened. use the compression forceps to achieve compression, or the distraction forceps to achieve distraction, and then tighten the setscrew as described in Step 12.

Note: All setscrews are designed to be flush or recessed from the top of the implant when locked. To ensure proper implant and rod (3.5 mm or 4.0 mm) configuration, please verify the part number of the implant.


Surgical technique

A. Place top loading hooks

Instruments


03.614.030 Implant holding Forceps



03.614.041* ratchet t- handle with quick coupling

03.614.050* dual Sided cap Inserter


Position hook

attach implant holding forceps to the appropriate hook. Place the hook in the desired location using the StardrIVe Screwdriver as an aid.

Insert rod

Insert locking screwtighten the locking screw using the StardrIVe Screwdriver Shaft with quick coupling handle. turn the screwdriver one-quarter to one-half turn counterclockwise to seat the thread before tightening.



addItIonal technIqueS



B. Insert top loading transconnectors

Note: The DePuy Synthes Spine SYNAPSE OCT System Top Loading Transconnector, compatible only with the SYNAPSE OCT System, is placed on top of two mono-segmental variable axis screws to cover the exposed spinal cord following laminectomy.

1 Insert transconnector locking screw

Instruments



loosely fasten the transconnector locking screws using the StardrIVe Screwdriver Shaft and 2 nm torque limiting handle. When inserting the transconnector locking screws, they may be turned one-quarter to one-half turn counterclockwise to seat the thread before tightening.

2Lock construct

Instruments


03.614.026 countertorque



03.614.027 Persuader

03.615.042* locking Persuader handle

after final adjustment of the construct, fully tighten all locking screws using the screwdriver shaft and 2 nm torque limiting handle. the construct is now rigidly locked. Final tightening should be accomplished after all locking screws have been placed, and should be aided by the countertorque tool.

Note: The persuader may be used in place of the countertorque.

additional techniques


3Insert transconnector

Instrument


Select a straight or angled transconnector of appropriate length. Place the transconnector on the DePuy Synthes Spine SYnaPSe oct System Screw construct to assess fit. hold the transconnector with the holding forceps. adjust as necessary. both sides of the transconnector should be placed over the locking screws before proceeding.

Note: Ensure the etched band on the transconnector shaft is not visible when implanting.

Caution: Do not bend the transconnector.


4Tighten locking nut

Instruments



03.614.040 transconnector nut driver, 7.5 mm

Select and place the locking nut onto the transconnector locking screw using the 7.5 mm nut driver. to provide alignment, insert the StardrIVe Screwdriver Shaft and 2 nm torque limiting handle into the cannula of the 7.5 mm nut driver and engage the t15 recess.

loosely thread the locking nut onto the transconnector locking screw using the 7.5 mm nut driver. after all locking nuts have been placed, firmly tighten them with the 7.5 mm nut driver, using the StardrIVe Screwdriver Shaft and 2 nm torque limiting handle as countertorque.

Tip: Use the 7.5 mm nut driver to help seat the transconnector onto the transconnector locking screw.

Note: When inserting the locking nuts, they may be turned one-quarter to one-half turn counterclockwise to seat the thread before tightening. Ensure the nuts are fully seated.

Caution: Use only one hand to tighten. Overtightening may make removal difficult. Do not turn the transconnector locking screw with the T15 while final tightening.

Optional technique

Instruments

03.614.048 t15 Shaft for torque limiting nut driver*

03.615.040 2.5 nm torque limiting nut driver*

to provide allignment, insert the t15 shaft for torque limiting nutdriver into the cannula of the torque limiting nut driver.

after locking nuts have been placed, firmly tighten them until the nut driver clicks.

* additionally available.



5 Lock connection

Instrument

388.038 crimper, for use with transconnector

Secure the locking sleeve with the crimper. When locking the connection, ensure that the gold tip of the instrument is touching the gold portion of the transconnector shaft. the transconnector is now rigidly locked.

Notes: If necessary, the connection can be unlocked using the same instrument with the gold tip touching the blue portion of the transconnector. Locking more than once may weaken the transconnector.

C. Adding rod-to-rod transconnectors

Instruments




388.038 crimper for transconnector


Position the transconnectorPlace the transconnector on the DePuy Synthes Spine SYnaPSe oct System rod construct. the transconnector may be held with the holding forceps.

unlocked

locked



Tighten clamp

tighten the setscrew of the transconnector hook on the rod with the StardrIVe Screwdriver Shaft. Slide the rod within the hook if necessary. hold the second hook in the appropriate position and tighten the setscrew.

Tip: The rod may be bent to accommodate the anatomy. Locking one end of the transconnector with the crimper may facilitate placement.


Lock connections

lock both bushing connections with the crimper. ensure that the gold tip of the instrument is facing medially when locking the connection. the transconnector is now rigidly locked.

Note: If necessary, the connection can be unlocked using the same instrument with the gold tip facing laterally. The rod may be shortened with the rod cutter.



D. Adding transverse bars

Instruments



Place the opening of the appropriate titanium transverse bar over the rod. loosely attach the transverse bar to the rod. Introduce the transverse bar into the variable axis head of the screw. Insert the locking screw in the variable axis head as described in Steps 11 and 12 of the SYnaPSe oct System technique. tighten the setscrew of the transverse bar using the StardrIVe Screwdriver Shaft.


E. Parallel connectors

open parallel connectors allow side loading of the rods. either side of the connector may be connected first. tighten the setscrew on one side, then connect the remaining rod and tighten the setscrews.




G. Occipital fusion technique

occipital plates or occipital clamps may be attached to the occiput as described in the Occipital Cervical Fusion System Technique. these plates or clamps can then be connected to the DePuy Synthes Spine SYnaPSe oct System.

F. Tapered rods

tapered rods may be used to extend a DePuy Synthes Spine SYnaPSe oct System construct. connect the 3.5 mm or 4.0 mm section to the SYnaPSe oct System polyaxial screws as instructed in Steps 8–10 of the surgical technique. con-nect the 5.0 mm/6.0 mm end of the rod to the appropriate uSS Spinal System.

the DePuy Synthes Spine SYnaPSe oct System may be linked to the DePuy Synthes Spine eXPedIuM 5.5 titanium Spine System using the 3.5 mm/5.5 mm and 4.0 mm/5.5 mm titanium tapered rods.



Implant removal

Instruments


03.614.039 cross Pinned hexagonal Screwdriver Shaft, quick coupling


all DePuy Synthes Spine SYnaPSe oct System implants can be removed with a t15 StardrIVe Screwdriver. the transconnectors also require that the crimper be used for removal.

Note: SYNAPSE OCT System Polyaxial Screws may also be removed with the cross pinned hex shaft, with quick coupling.

Removing top loading transconnectors

Instrument


Alternative Instrument

03.615.040* 2.5 nm torque limiting nut driver

Remove nutto remove the top loading transconnector, remove the nut using the 7.5 mm nut driver.



IMPlant reMoVal

Option A

Remove transconnector

Instruments



use the StardrIVe Screwdriver Shaft and 2 nm torque limiting handle to unlock the locking screw and remove the transconnector.

Remove transconnector locking screw

Instruments



use the StardrIVe Screwdriver Shaft and 2 nm torque limiting handle to remove the transconnector locking screw.


Implant removal

Option B


Instrument

03.615.041* top loading Implant remover

First, remove the nuts from the top loading implant.

ensure the inner shaft has not been advanced too far before placing over the screw/transconnector interface, otherwise instrument will not engage.

engage the distal end of the instrument to bottom of the implant. While aligning the implant remover to the axis of the transconnector locking screw, slowly turn the knob to thread the handle down. continue turning slowly until the implant become released from the transconnector locking screw.

*additionally available


Implant removal

Option C


Instruments



Remove the 7.5 mm locking nuts

grip the transconnector loop midline using the holding forceps.

loosen the interface by rocking the transconnector loop cranially-caudally, as needed to release. Move to the opposite loop and repeat. once loosened, remove the transconnector.


Implant removal


button

“ Speed bump”

outer sleeve

aSSeMblY guIde

Instruments

03.614.017 holding Sleeve with thread

03.614.039 hexagonal Screwdriver Shaft, cross pinned

324.107 handle with quick coupling

Optional instrument

03.614.036 outer Sleeve for holding Sleeve no. 03.614.017

• add the outer sleeve to the holding sleeve. Insert the holding sleeve through the slotted end of the outer sleeve past the threads of the holding sleeve. Snap the outer sleeve over the “speed bump.” (Fig 1)

• Insert the back end of the cross pinned hexagonal screwdriver shaft through the distal tip of the holding sleeve (Fig 2). Press the button on the holding sleeve while inserting the screwdriver shaft. ensure that the holding sleeve has bottomed out on the cross pin at the distal end of the screwdriver shaft.

• connect the handle with quick coupling to the hexagonal screwdriver shaft (Fig 3).

• reset the driver by pressing the button on the sleeve and pulling back on the sleeve until it hits the handle (Fig 4). the green color band on the sleeve should not be visible.

driver is ready for use.

Figure 1 Figure 2 Figure 3 Figure 4

green color band

ScreWdrIVer


Attach screwdriver to polyaxial screw• ensure that the driver is in the reset position. the green

color band on the holding sleeve should not be visible.• Insert the tip of the hexagonal screwdriver shaft into the

bone screw of the polyaxial screw (Fig 5).• Slide the sleeve until it comes in contact with the body

of the polyaxial screw (Fig 6).• rotate the sleeve clockwise until it bottoms out on the

cross pin of the hexagonal screwdriver shaft (Fig 7). the green color band should be visible. the polyaxial screw is ready for bone insertion.

Remove screwdriver from the polyaxial screw• rotate the sleeve counterclockwise. before accepting

another polyaxial screw, the driver should be reset as shown in Figure 4. the green color band on the holding sleeve should not be visible.

Figure 5 Figure 6 Figure 7

assembly guideScrewdriver


1

2

3

1

2

PerSuader InStruMent (03.614.027)

assembly guide

3

1

2


1

1

2

1

2

assembly guide

turn-to-lock drill guide for 2.4 mm drill bit 03.615.030

drill guide with graduation for 2.4 mm drill bit 388.393

drIll guIdeS


1

2

3

4

dePth gauge (03.161.028)

assembly guide


SYNAPSE 4.0 mm Rod System SYNAPSE 3.5 mm Rod System

Features and Design

Rods 4.0 mm titanium tapered rod 3.5 mm titanium tapered rod

4.0 mm titanium Straight rod 3.5 mm titanium Straight rod

4.0 mm titanium Pre-curved rod 3.5 mm titanium Pre-curved rod

Screws accommodate 4.0 mm rods and 3.5 mm rods accommodate 3.5 mm rods

Polyaxial

one piece body

top-loading

Square thread locking screw

t15 StardrIVe recess

3.5 mm titanium cancellous Screws 3.5 mm titanium cancellous Screws 8 mm – 50 mm (2 mm increments) 8 mm – 50 mm (2 mm increments) 50° maximum angulation 50° maximum angulation



3.5 mm titanium cortex Shaft Screw 3.5 mm titanium cortex Shaft Screw 18 mm – 50 mm (2 mm increments) 18 mm – 50 mm (2 mm increments) 40° maximum angulation 40° maximum angulation

Hooks Side-loading lamina hooks not offered with lamina hooks (side-loading) the 4.0 system left and right offset t15 StardrIVe recess

top-loading lamina hooks left, right, and straight offsets Short and long versions

Transconnector top-loading transconnector

4.0 mm rod-to-rod transconnector 3.5 mm rod-to-rod transconnector

transconnector locking Screw and 7.5 mm locking nut

Additional components 4.0 mm transverse bars and open Parallel 3.5 mm transverse bars and open connectors Parallel connectors

SYnaPSe oct SYSteM coMPatIbIlItY MatrIX


occIPItal cerVIcal FuSIon SYSteM Implants and instruments designed to optimize fi xation to the occiput

the DePuy Synthes SYnaPSe oct System additionally contains implants and instruments that are intended to provide immobilization and stabilization as an adjunct to fusion of the occipito cervical junction. the oc Fusion System includes a complete set of implants and instruments designed to optimize fi xation to the occiput and easily connect with DePuy Synthes Spine cervical and thoracic Systems.

Featuresthe oc Fusion System offers the surgeon several implant options to maximize fi xation to the occiput and minimize the implant footprint. the instrumentation is designed to accommodate minimal exposures and varying patient anatomy.

Midline plate construct Lateral wedge plate construct

Instruments• Slender design maximizes visualization• universal joint and fl exible instruments accommodate

minimal exposures• depth control on drills and taps adapt to varying

patient anatomy


One-hole clamp construct

Two-hole clamp construct

Plate/rod construct

occipital cervical Fusion System


4.0 mm Plate/rods

4.0 mm Pre-bent rods

OC Fusion implants for DePuy Synthes Spine SYNAPSE OCT System 4.0 mm Rods (or plate/rod)

When used in conjunction with the DePuy Synthes Spine SYnaPSe 4.0 System, specific 4.0 mm implants are necessary.

4.0 mm Midline Plate 4.0 mm lateral Wedge Plate

one-hole and two-hole clamps for 4.0 mm rods

4.0 top loading oc connector

occipital cervical Fusion System


PreParatIon

1Preparation

Required sets

01.601.020e occipital cervical Fusion Instrument and titanium Implant Set

01.614.001e SYnaPSe Instrument and titanium Implant Set or 01.615.006e SYnaPSe 4.0 mm rod Instrument and titanium Implant Set

Optional sets



01.614.001

01.601.020


2Preoperative planning

all necessary imaging studies should be available to plan occipital screw placement and accommodate varying patient anatomy.

3Position patient

Patient positioning is critical for occipitocervical fusion procedures. the patient should be placed on the operating table in the prone position with the patient’s head securely immobilized. confirm proper patient position by direct visualization before draping, and by radiograph. always use caution when positioning the patient, as physiological alignment may not be attainable.

4Approach

Make a standard midline incision from the external occipital protuberance and continue caudally, to appropriately expose the cervical/thoracic levels to be surgically treated.

Preparation


occIPItal Plate technIque

1Attach bone anchors

attach bone anchors to the cervical and thoracic spine asdescribed in the DePuy Synthes Spine SYnaPSe oct System, and aXon Pedicle Screw System technique guides.

2Select occipital plate

Instruments

03.161.0xx template, for occipital Plate

387.689 Plate holder

Select a template of the plate style and size estimated to best fit the occiput, as determined by the separation of the rods. contour the template to fit the anatomy.


3Contour plate

Instrument

03.161.042 Plate bender

use the plate bender to contour the plate to fit the anatomy, using the template as a guide. the plate bender can be used across any section of the plate, including the area lateral to the rod attachment bodies.

Note: Reverse bending of the plates should not be attempted. Extreme bending over the rod attachment body travel slot will limit the amount of medial/lateral adjustment in the rod attachment body.


391.88 locking Pliers

locking pliers can be used to create more acute bends.

Note: Reverse bending of the plates should not be attempted. Extreme bending over the rod attachment body travel slot will limit the amount of medial/lateral adjustment in the rod attachment body.

occipital Plate technique




Instrument

03.161.023 adjustable drill guide

Set the adjustable drill guide to the desired depth. Slide back the latch to release the inner tube. align the indicator of the inner tube with the appropriate depth calibration on the outer tube. release the latch to lock the drill guide at the desired depth.


5Drill

Instruments


03.161.024 3.2 mm drill bit


387.689 Plate holder

Caution: Do not touch the latch when drilling. Touching the latch could disengage the lock, resulting in uncontrolled depth and potential harm to the patient.

drill a hole to the desired trajectory and depth, using the 3.2 mm drill bit through the adjustable drill guide. drill to the stop. drilling must occur through the occipital plate to ensure proper drilling depth.


03.161.104 3.2 mm drill bit with Flexible Shaft

03.161.105* 3.2 mm drill bit with Flexible Shaft (new)


drill a hole to the desired trajectory and depth, using the 3.2 mm drill bit with flexible shaft through the adjustable drill guide. drill to the stop. drilling must occur through the occipital plate to ensure proper drilling depth.





6Measure

Instrument




7Tap

Instruments


03.161.026 tap for 4.5 mm occipital Screws

324.107 quick coupling handle

Caution: Do not touch the latch when tapping. Touching the latch could disengage the lock resulting in uncontrolled depth and potential harm to the patient.

tap through the adjustable drill guide and occipital plate, to ensure proper tapping depth.

Note: Tapping is required for all screws.


Instruments

03.161.027 universal Joint tap for 4.5 mm occipital Screws


Caution: Do not touch the latch when tapping. Touching the latch could disengage the lock resulting in uncontrolled depth and potential harm to the patient.

Set the tap depth by turning the tap sleeve to the desired depth. lock the tap sleeve by turning down the locking nut to contact the tap sleeve. Finger-tighten the lock nut. use the holding forceps to provide axial force and stability. tapping must occur through the occipital plate to ensure proper tapping depth.




8Insert screw

Instruments


388.392 StardrIVe, locking Screwdriver Shaft, t15

Optional Instruments



Insert the selected 4.5 mm occipital screw and provisionally tighten.

Note: A 5.0 mm emergency screw may be used if the primary screw has less than optimal fixation.


Instruments

03.161.031 universal Joint Screwdriver, t15






use the universal joint screwdriver to insert the selected screw. use the holding forceps to provide axial force and stability.



9Insert additional screws

Insert remaining screws, as in Steps 4–8.

10Contour rod template

Instrument

388.868 rod template, 240 mm (3.5 mm and 4.0 mm rods)

contour the rod template to fit the anatomy and to seat fully in the cervical and upper thoracic bone anchors. create the occipitocervical bend and ensure sufficient rod length to connect with the occipital plate.




11Bend rod

Instruments



contour the 3.5 mm or 4.0 mm rod to match the template. use the rod cutter to cut the rod to the appropriate length.

Caution: Repeated bending may weaken the rod.

Optional technique

Instruments:

03.614.055* template for oc rod angles

Measure the oc angle using template for oc rod angles.Select a rod to match the angle as revealed by the template.

Note: If template reading shows it to be between 2 sizes, choose the larger angle.



12Attach rods

Instruments

03.161.041 Positioning tool or 03.615.007 Positioning tool, for 4.0 mm rod



Insert rods into the rod attachment body. ensure that the rods extend slightly past the end of the plate. use the locking screwdriver shaft to insert the titanium locking screw. use the positioning tool to facilitate rod placement and locking screw insertion.





03.614.050* dual Sided locking cap Inserter


use the universal joint screwdriver and holding forceps to insert the titanium locking screw.




13Final tightening

Instruments



use the locking screwdriver shaft for final tightening of all occipital screws and locking screws.





03.688.505* Small ratchet with quick coupling

use the universal joint screwdriver and the holding forceps for final tightening of all occipital screws and locking screws.




occIPItal FuSIon connectorS

Optional technique

From Step 9, follow the surgical technique below if oc fusion connectors are used.

1Insert transconnector locking screw

Instrument

03.614.019 StardrIVe Screwdriver Shaft, t15, self retaining, quick coupling

03.614.035 2 nm torque limiting handle, with quick coupling

loosely fasten the transconnector locking screws to the sub-occipital bone anchors using the StardrIVe Screwdriver Shaft and 2 nm torque limiting handle. When inserting the transconnector locking screws, they may be turned one-quarter to one-half turn counterclockwise to seat the thread before tightening.

2trial using the rod template, by seating the template into the occipital plate saddle and creating the bend angle necessary to reach the sub-axial bone anchor.

contour a straight or angled oc connector to match the trialed rod.

Instruments

388.868 rod template



Caution: Do not bend the loop/bushing interface.


oc Fusion connectors

3Insert Occipital Connector

Instrument

388.407 holding Foreceps

Place the top loading connector over the transconnector locking screw using the holding forceps and adjust as necessary.

4Insert locking screw into the occipital plate

Instrument


use the positioning tool to facilitate rod placement and locking screw insertion. Provisionally tighten locking screw (do not final tighten).

Caution: Ensure the rod is flush with the plate and the bend of the rod does not interface with the locking screw.


6Final tighten the OC locking screw

Instruments






use the locking screwdriver shaft for final tightening of all occipital screws and locking screws.


5Insert the locking nut

Instruments


03.614.048 t15 Shaft for torque limiting nut driver



03.615.040* 2.5 nm torque limiting nut driver




Place the locking nut onto the transconnector locking screw using the torque limiting nut driver. Insert the straight StardrIVe, t15 Shaft, into the cannula. Provisionally tighten locking nut (do not final tighten).




7Final tighten the locking nut

Instruments

03.614.048 t15 Shaft for torque limiting nut driver

03.615.040 2.5 nm torque limiting nut driver







Final tighten both locking nuts using the 2.5 nm torque limiting nut driver.

Note: If removal is required, please refer to page 30–37 and follow the same removal technique as the Transconnector.



occIPItal claMP technIque




Instrument

388.868 rod template, 240 mm (for 3.5 mm and 4.0 mm rod)

contour the rod template to fit the anatomy and to seat fully in the cervical and upper thoracic bone anchors. create the occipitocervical bend and ensure sufficient rod length to connect with the occipital clamp.


occipital clamp technique

3Bend rod

Instruments





4Place clamp on rod

Instruments



Provisionally place the occipital clamp on the titanium rod by tightening the setscrew in the clamp to engage the rod.



Instrument






6Drill

Instruments


03.161.024 3.2 mm drill bit




drill a hole to the desired trajectory and depth, using the 3.2 mm drill bit through the adjustable drill guide. drilling must occur through the occipital clamp to ensure proper drilling depth.





drill a hole to the desired trajectory and depth, using the 3.2 mm drill bit with flexible shaft through the drill guide. drilling must occur through the occipital clamp to ensure proper drilling depth.



7Measure

Instrument


use the depth gauge to confirm hole depth and select thecorresponding screw length. the depth gauge reading and the screw length indicate actual bone purchase. the depth gauge must sit directly on the bone.




8Tap

Instruments






Caution: Do not touch the latch when tapping. Touching the latch could disengage the lock, resulting in uncontrolled depth and potential harm to the patient. tap through the adjustable drill guide and occipital clamp, to ensure proper tapping depth.



Instruments



Caution: Do not touch the latch when tapping. Touching the latch could disengage the lock, resulting in uncontrolled depth and potential harm to the patient.

Set the tap depth by turning the tap sleeve to the desired depth. lock the tap sleeve by turning down the locking nut to contact the tap sleeve. Finger-tighten the lock nut. use the holding forceps to provide axial force and stability. tapping must occur through the occipital clamp to ensure proper tapping depth.



9Insert screw

Instruments






Insert the selected 4.5 mm occipital screw.

Note: A 5.0 mm rescue screw may be used if the primary screw has less than optimal fixation.




use the universal joint screwdriver to insert the selected 4.5 mm occipital screw. use the holding forceps to provide axial force and stability.





10Insert additional screws and clamps

Insert remaining screws and clamps, as in Steps 4–9. a minimum of 2 clamps per rod is required.


11Final tightening

Instruments



use the locking screwdriver shaft for final tightening of all occipital screws and clamp setscrews.




031.614.041 ratchet t-handle with quick coupling*

03.688.505 Small ratchet handle with quick coupling*

use the universal joint screwdriver and the holding forceps for final tightening of all occipital screws and clamp setscrews.




occIPItal Plate/rod technIque




Instrument

03.161.003 template, for occipital Plate/rod

contour the template to fit the anatomy and to seat fully in the cervical and upper thoracic bone anchors.


3Bend rod

Instruments






Instrument



occipital Plate/rod technique



5Drill

Instruments


03.161.024 3.2 mm drill bit




drill a hole to the desired trajectory and depth, using the 3.2 mm drill bit through the adjustable drill guide. drilling must occur through the occipital plate/rod to ensure proper drilling depth.





drill a hole to the desired trajectory and depth, using the 3.2 mm drill bit with flexible shaft through the adjustable drill guide. drilling must occur through the occipital plate/rod to ensure proper drilling depth.



6Measure

Instrument






7Tap

Instruments





tap through the adjustable drill guide and plate, to ensure proper tapping depth.






Set the tap depth by turning the tap sleeve to the desired depth. lock the tap sleeve by turning down the locking nut to contact the tap sleeve. Finger-tighten the lock nut. tapping must occur through the occipital plate/rod to ensure proper tapping depth.


8Insert screw

Instruments






Insert the selected 4.5 mm occipital screw.

Note: A 5.0 mm emergency screw may be used if the primary screw has less than optimal fixation.




use the universal joint screwdriver to insert the selected 4.5 mm occipital screw. use the holding forceps to provide axial force and stability.




Implant removal

all occipital cervical Fusion System implants can be removed with a t15 StardrIVe Screwdriver.


9Insert additional screws

Insert remaining screws as in Steps 4–8. a minimum of three screws per plate/rod is required.


oc FuSIon SYSteM coMPatIbIlItY MatrIX

Occipital Plates the occipital Plate is available as a medial or lateral wedge, 50 mm or 60 mm wide. the plate attaches to occiput with screws

low-profile plate, 2 mm thick

rod attachment height, 8.5 mm

bend grooves

bead-blasted to minimize slippage

15° screw angulation

rod connection points are variable to allow for rotation and lateral/medial adjustment

titanium occipital Plate, medial, for 4.0 mm rods titanium occipital Plate, medial, for 3.5 mm rods

titanium occipital Plate, lateral wedge, for titanium occipital Plate, lateral wedge, 4.0 mm rods for 3.5 mm rods

Occipital Screws 4.5 mm and 5.0 mm titanium occipital Screws, 4 mm–18 mm long in 2 mm increments lengths denote screw purchase

larger screw core provides increased strength

Screw pitch reduced to provide additional purchase and tactile feedback during insertion

Clamps titanium occipital clamp, 2 holes (4.0 mm) titanium occipital clamp, 2 holes (3.5 mm)

titanium occipital clamp (4.0 mm) titanium occipital clamp (3.5 mm)

Rods rods attach to plate with 4.0 mm capable rods attach to plate with 3.5 mm locking screws capable locking screws

Straight and Pre-bent rod

4.0 mm rod, 240 mm 3.5 mm rod, 240 mm

rods attach to cervical spine with clamps, plates, or plate/rod

Locking Screw SYnaPSe oct System locking Screw aXon locking Screw

OC Fusion Connectors 4.0 mm top loading oc Fusion connectors 3.5 mm top loading oc Fusion connectors

OC Fusion System with 4.0 mm Rod OC Fusion System with 3.5 mm Rod

Limited Warranty and Disclaimer: DePuy Synthes Spine products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.

WARNING: In the USA, this product has labeling limitations. See package insert for complete information.

CAUTION: USA law restricts these devices to sale by or on the order of a physician.

To order in the US, call Johnson & Johnson Health Care Systems Inc. Customer Support Services at 800-255-2500.

not all products are currently available in all markets.

This surgical technique is not intended for distribution in Canada.

© dePuy Synthes 2015. all rights reserved.dSuS/SPn/1114/0576(1) 3/15 dV

Manufactured or distributedin the United States by:

Synthes USA, LLC1101 Synthes avenueMonument, co 80132tel: +1 (800) 227-6633

www.depuysynthes.com

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