variax fibula locking plate system - kategorizacia.mzsr.sk

VariAx FibulaLocking Plate System

• Distal Fibula Fracture Repair• Polyaxial Locking Technology• Low Profile Design

Operative Technique

Contributing Surgeon:

Bradley R. Merk, MD

Associate Professor of Orthopaedic Surgery

Director of Orthopaedic Trauma

Feinberg School of Medicine

Northwestern University

Chicago, USA

This publication sets forth detailedrecommended procedures for usingStryker Osteosynthesis devices andinstruments.

It offers guidance that you shouldheed, but, as with any such technicalguide, each surgeon must considerthe particular needs of each patientand make appropriate adjustmentswhen and as required.

A workshop training is required priorto first surgery.

See package insert for a complete listof potential adverse effects, contrain-dications, warnings and precautions.The surgeon must discuss all relevantrisks, including the finite lifetime of the device, with the patient, whennecessary.

Warning:All bone screws referenced in thisdocument here are not approvedfor screw attachment or fixation tothe posterior elements (pedicles)of the cervical, thoracic or lumbarspine.

Page

1. Introduction 4

2. Features & Benefits 5

3. Overview 6

Plate Options 6

Screw Options 6

4. Indications, Precautions & Contraindications 7

5. Operative Technique 8

Planning and Preparation 8

Preparation for Screw Insertion 10

Screw Insertion 13

Final Steps 13

Optional: Independent Lag Screw Technique 14

Optional: Syndesmotic Screw Fixation Technique 16

Ordering Information - Implants 17

Ordering Information - Instruments 20

Ordering Information - Cases & Trays 23

Table of Contents

3

• The VariAx Fibula Locking Plate System represents a new generation of implant technology The reconstruction and fixation of distal fibular fractures can now be enhanced by means of the patented SmartLock polyaxial locking mechanism. This powerful feature allows a surgeon to insert polyaxial locking or non-locking screws at variable angles with respect to the plate, so that they can be targeted to address the location and geometry of any given fracture, without the constraint of existing monoaxial plate designs or screw trajectories.

• Patented Polyaxial Locking Technology

Each screw is made of titanium alloy, which is slightly harder than the plates. When a locking screw is used, the thread in the head of the screw reshapes the titanium used in the plate, thus allowing for a secure form-fitting geometry. This process is designed to result in a solid, locked connection between the head of the screw and the plate.

• Unique One-Step Locking Achieved by simply inserting a

locking screw within the polyaxial locking range of ±15°, without the need for further steps.

• Modular System Design The modular instrumentation system

is designed for seamless integration of other products from the Stryker Foot portfolio.

• Color-Coding of Instruments The instruments are color-coded to

facilitate ease-of-use during surgery.

The SmartLock Locking Technology is patented (US 6,322,562; DE 43 43 117; EP 1 143 867) by Professor Dietmar Wolter, Hamburg, Germany.

Introduction

4

-15° +15°

• Precontoured Periarticular Plate Design

The precontoured shape of the VariAx Fibula Plates was carefully designed using a comprehensive CT scan database of human fibulas. The end result is a precontoured plate that closely matches the average anatomical shape of the distal fibula, and thus requires minimal intra-operative plate contouring*.

• Low Profile Plate Design and Reduced Screw Head Prominence

Each plate is designed to minimize soft tissue irritation by having a low profile design (only 1.3mm distally, and 2.0mm in the shaft portion). Furthermore, the screws are designed to have minimal head prominence when fully inserted in a plate, which helps further reduce the risk of irritation.

• K-Wire Holes in the Plate

To allow for temporary fixation in order to ease plate application.

• A Clustering of Distal Screws

Allows for multiple points of fixation to treat comminuted fractures or fractures with limited distal bone stock.

• Full-Range of 3.5mm Locking and Non-Locking Screws

Offers intraoperative solutions to cover a broad range of clinical situations.

• Polyaxial Drill Guide

Allows placement of locking screws at a variable angle (up to ± 15°).

• Efficient T10 Screw Head Design

All 3.5mm VariAx Fibula Locking Plate screws are designed with a T10 head. This screw head design facilitates efficient force transmission from the screwdriver blade to the screw, and helps reduce the risk of screw head stripping.

• Anodization Type II

• Optional Independant lag Screw Fixation

A full range of non-locking VariAx screws are available for placement of independent lag screws.

Features & Benefits

* MEM Research Center ISTB Fibula Bone Implant Fitting Project

5

Plate Options

Fibula Plate

The fibula plate only accepts 3.5mm screws

Overview

3.5mmLocking

3.5mmNon-

Locking

Range 3 Holes - 12 Holes

Length 77mm - 185mm

6

Screw Options

Indications, Precautions & Contraindications

The following contraindications may be of a relative or absolute nature, and must be taken into account by the attending surgeon:

• Patients with active infections or suspected latent infection, or marked local inflammation in or about the affected area

• Patients with limited blood supply

• Bone stock compromised by disease, infection or prior implantation

• Patients with metal allergies and foreign body sensitivity

• Obesity

• Patients having inadequate tissue coverage over the operative site

• Severely non-compliant patients with mental or neurological conditions who are unwilling or incapable of following postoperative care instructions

• Other medical or surgical conditions which would preclude the potential benefit of surgery

• Inadequate bone quantity and quality

• Patients with unstable physical and/ or mental health conditions

IndicationsThe VariAx Distal Lateral Fibula Locking Plate System is intended for use in internal fixation of the distal fibula. The physician’s education, training and professional judgment must be relied upon to choose the most appropriate device and treatment option.

Examples of Applications

• Weber A, B, C fractures of the distal fibula with and without syndesmotic injury

• Distal Fibula non-unions and malunions.

See package insert for warnings, precautions, adverse effects and other essential product information.

The VariAx Fibula System has not been evaluated for safely and compatibility in the MR environment. The VariAx Fibula System has not been tested for heating or migration in the MR environment.

Warnings and Precautions

Relative Contraindications

7

Planning and Preparation

The Operative Technique listed below is designed to provide a general overview on the instruments and procedure required to implant a VariAx Fibula Plate.

Clear identification and classification of the fracture site should first be established preoperatively using the appropriate methods and visualization.A lateral incision is typically used to perform an extra-periosteal exposure of the distal fibula. A direct reduction and provisional fixation of the fracture can frequently be achieved. If the fracture morphology is amenable, an independant lag screw can be inserted first (see page 14). Alternatively,indirect reduction techniques may be employed such as a distal lateral fibula plate.

VariAx Fibula Plates can be removed from the plate tray and handled using the Forceps (64-20129), as shown.

Although the plates are pre-contoured, additional contouring of the plates is possible using the Plate Bending Pliers (45-80010) when required based on local patient factors or anatomy. In order to reduce the likelihood of stress riser effect and reduce the fatigue properties of the implant, care should be taken to bend the plate in between holes.

Please note: Excessive plate bending may lead to failure of the locking mechanism and should be avoided.

Operative Technique

8

Having achieved reduction, the plate is selected and applied to the direct lateral surface of the distal fibula. The position should be adjusted to optimize fit and to allow for optimal screw fixation as per the fracture pattern and the preoperative plan.Fluoroscopy can be utilized as needed to confirm position. The plate can then be stabilized by the insertion of K-Wires to ensure anatomical alignment (proximally and distally).

VariAx Fibula Plates include K-Wire holes that are designed to accommodate 1.4mm Trocar Tipped K-Wires (45-80200), for use in temporarily stabilizing the plate to bone.

The K-Wire Cutting Pliers (45-80020) can be used to cut the K-Wires to the desired length. This instrument includes a silicon inlay which prevents the cut end of a K-Wire from being ejected from the instrument.

Operative Technique

9

A drill guide must first be placed into a corresponding plate screw hole (in a plate), prior to pre-drilling a pilot hole. The Drill Guide for Circular Locking Holes (45-80001) must be used in all VariAx Fibula Plate holes. Use the end of the drill guide indicated with yellow color-coded lines to predrill for VariAx Fibula plating procedures. Yellow color-coding is associated with 3.5mm VariAx Foot and Ankle screws.

Please note: The other end of the drill guide is indicated with black color- coded lines, and is designed for use with VariAx Foot and Ankle Plates that accept 2.7mm screws. This end of the drill guide must not be used for VariAx Fibula procedures.

The drill guide is designed to limit drilling to a ±15° angle with respect to the plate. Drilling at an angle greater than ±15° may prevent locking from taking place, and should be avoided.

Always use the drill guide when predrilling a pilot hole, either for a locking or non-locking 3.5mm screw.

Note: Drill guides should always fit securely within a screw hole – a mismatch between the drill guide and the plate hole indicates that the wrong dimension drill guide has been chosen.

Preparation for Screw Insertion

Operative Technique

10

Use the drill to create a pilot hole through the drill guide. The 2.6mm Twist Drill (45-35010) is color-coded yellow to match the color associated with the 3.5mm drill guide.

Although the locking and non-locking screws found in the VariAx Foot and Ankle system are self-tapping, when encountering hard bone a tap may be required. For 3.5mm screws the appropriate tap is similarly color-coded yellow (45-35005).

Measure the depth of the predrilled hole using the Depth Gauge for 3.5mm screws (45-35001). As with the drills and drill guides, the appropriate depth gauge is color-coded with yellow lines indicating use with 3.5mm screws. Always measure the depth of the predrilled hole by inserting the depth gauge first through the plate, and then into the predrilled hole.

Use depth gauge to attain appropriate screw length. The sleeve of the depth gauge must be fully inserted into the respective plate hole prior to measuring. Measuring without a plate will result in a false reading.


Operative Technique

11


Holding sleeves for screws can be used to securely attach a screw to the screwdriver during screw insertion. The yellow color-coded Holding Sleeve for 3.5mm screws (45-35030), must be used. Assemble the appropriate holding sleeve and slide it over the screwdriver until it engages, as shown.

Assemble the appropriate Screwdriver Blade (with AO fitting) with the Screwdriver Handle, Revolving/Rigid, AO (45-85000).

Please note: Only the yellow color-coded Screwdriver Blade, AO, T10 (45-35015) is used to insert 3.5mm screws.

Begin by pushing the AO quick-connect sleeve towards the body of the Screwdriver Handle, insert the screw-driver blade into the AO quick-connect coupling, and then release the sleeve.

Operative Technique

12

Push the holding sleeve back so that the tip of the screwdriver becomes visible. Engage the screwdriver tip with the head of the chosen screw, then push the holding sleeve forward, as shown. The holding sleeve will engage with the head of the screw, firmly holding it in place. The screw can then be removed securely from the screw rack, and the screw can be inserted into the plate.

Screw InsertionInsert the screw into the predrilled hole using the screwdriver assembly.

As the screw head approaches the plate, draw the holding sleeve back from the screw head, and continue with final tightening then remove the screwdriver from the screw.

Repeat drilling, measuring, and placement of locking or non-locking screws in the remaining holes, as required. Always remember to use the appropriate sized drill guide.

Operative Technique

Final Steps• The highly efficient T10 interface (for 3.5mm screws) facilitates effective transmission of torque from the screwdriver blade to the screw.

• Intraoperative fluoroscopy is performed to confirm appropriate reduction and implant placement

• Additional surgical approaches and fixations (e.g. for the medial and/or posterior malleolar fractures) are then performed.

13

Optional: Independent Lag Screw Technique

Operative Technique

A 3.5mm VariAx Foot and Ankle Non-Locking Screw can be used as an independent lag screw to reduce fibula fractures, prior to fixation using a VariAx Fibula plate. The VariAx Foot and Ankle instrumentation system includes a Drill Guide for a 3.5mm Independent Lag Screw (45-80003), which is designed to only be used when drilling and overdrilling a hole for independent lag screw fixation using a 3.5mm screw. This technique must not be performed through a plate.

The procedure for preparing a hole for independent lag screw insertion is as follows:

1. Anatomic reduction is achieved and maintained with a pointed reduction clamp.

2. Identify the appropriate drill guide. For 3.5mm screws, use the Drill Guide for 3.5mm Independent Lag Screws (45-80003). This drill guide has two sides/sleeves. Identify the side labeled “Near Fragment”, which is also color-coded. For 3.5mm independent lag screw fixation, the near fragment side of the appropriate drill guide will have yellow and red lines on the drill sleeve, and a red “window”.

3. The correct overdrill is directly placed against bone for drilling the near fragment. For 3.5mm screws, use the overdrill that is color-coded with a red and yellow line. (45-35020) (color- coded with a red and yellow line)

4. The red and yellow color-coded drill bit is then inserted through the identical red and yellow drill guide, and drilling is performed completely through the near fragment to create a gliding hole. This drilling must completely pass through the near fragment, and into the interfragmentary space, otherwise lagging of the far fragment will not be possible.

1414

5. The other side of the drill guide, which is yellow color-coded, is then fully inserted into the newly created gliding hole. For 3.5mm screws, the drill sleeve will have a yellow color-coding. This drill guide must be inserted as deep as possible into the overdrilled hole. The appropriate yellow color-coded 2.6mm drill (45-35010) is then chosen. Drilling is performed using the appropriate drill, into the far fragment. The end result of the drilling process will be a co-linear hole through the near fragment, and into the far fragment, where the diameter of the hole in the near fragment will be bigger than the diameter of the hole in the far fragment (thus allowing for lagging).

6. When appropriate, use the countersink (45-80040) to minimize screw head prominence and reduce stress riser effects to the bone during final screw tightening.

7. Screw length is then measured using the Depth Gauge for 3.5mm screws (45-35001).

8. The screw can then be inserted. A washer (40-35900) could also be used if necessary due to bone quality. If a washer is intended to be used the countersink should not be applied before.

Operative Technique

15

Operative Technique

Optional: Syndesmotic Screw Fixation Technique• After completion of all fixation an intra-operative Cotton test or external rotation stress test is performed under fluoroscopy and syndesmotic reduction and fixation is performed as needed.

- A stab incision is made medially near the metaphysis.

- A large peri-articular clamp is used to obtain and maintain an anatomic syndesmotic reduction which should be confirmed fluoroscopically on the AP, mortise, lateral view by inspection or palpation via the surgical exposure. Using the drill guide the 2.6mm yellow color-coded drill bit is used to make a pilot hole parallel to the tibio-talar articulation and the trans-malleolar axis. Care must be taken to avoid excessive angulation through the plate beyond 15°.

• One or two tri-cortical or tetra-cortical 3.5mm non-locking screws can be used to achieve syndesmotic fixation based on patient factors, injury factors, and surgeon preference.

For Bi Malleolar Fractures

Asnis III

4mm 5mm

16

Ordering Information - Implants

3.5mm LOCKING SCREWS Quantity per Quantity per REF Description Foot Set Fibula Set

40-35610(S) Locking Screw, T10, 3.5x10mm 4 6

























3.5mm NON-LOCKING SCREWS Quantity per Quantity per REF Description Foot Set Fibula Set

40-35010(S) Bone Screw, T10, 3.5x10mm 4 6

40-35012(S) Bone Screw, T10, 3.5x12mm 4 6

40-35014(S) Bone Screw, T10, 3.5x14mm 4 9

40-35016(S) Bone Screw, T10, 3.5x16mm 4 6

40-35018(S) Bone Screw, T10, 3.5x18mm 4 6

40-35020(S) Bone Screw, T10, 3.5x20mm 4 6

40-35022(S) Bone Screw, T10, 3.5x22mm 4 3

40-35024(S) Bone Screw, T10, 3.5x24mm 4 3

40-35026(S) Bone Screw, T10, 3.5x26mm 4 3

40-35028(S) Bone Screw, T10, 3.5x28mm 4 3

40-35030(S) Bone Screw, T10, 3.5x30mm 4 0

40-35032(S) Bone Screw, T10, 3.5x32mm 4 0

40-35034(S) Bone Screw, T10, 3.5x34mm 4 0

40-35036(S) Bone Screw, T10, 3.5x36mm 4 0

40-35038(S) Bone Screw, T10, 3.5x38mm 4 0

40-35040(S) Bone Screw, T10, 3.5x40mm 4 0

40-35042(S) Bone Screw, T10, 3.5x42mm 4 0

40-35044(S) Bone Screw, T10, 3.5x44mm 4 0

40-35046(S) Bone Screw, T10, 3.5x46mm 4 0

40-35048(S) Bone Screw, T10, 3.5x48mm 4 0

40-35050(S) Bone Screw, T10, 3.5x50mm 4 0

40-35055(S) Bone Screw, T10, 3.5x55mm 4 0

40-35060(S) Bone Screw, T10, 3.5x60mm 4 0

40-35065(S) Bone Screw, T10, 3.5x65mm 4 0

40-35070(S) Bone Screw, T10, 3.5x70mm 4 0

17


PLATES Length Quantity per REF Description mm Set

40-20903(S) VariAx Fibula Plate, 3 holes 77 2







40-20910S VariAx Fibula Plate, 10 holes 161 0

40-20912S VariAx Fibula Plate, 12 holes 185 0

Plate Specifications mm

Thickness Shaft 2.0

Distal End 1.3

Width Shaft 10

Width Distal End 16

18


Quantity per Quantity per REF Description Basic Set Deluxe Set

40-35900(S) Washer for 3.5mm Screw 0 10


45-80100(S) K-Wire, Fully Threaded, 1.6mm x 200mm 4 4

45-80200(S) K-Wire, Smooth, 1.4mm x 100mm 4 4

WASHERS

K-WIRES & STEINMANN PINS

19

Ordering Information - Instruments

Quantity per REF Description Foot Set

Instruments

45-35010(S) Drill, 2.6mm x 122mm, WL70mm, AO-Shaft 2

45-35005(S) Tap for 3.5mm Screws, AO, 70mm 1

45-35001 Depth Measuring Gauge for 3.5mm Screws 1

45-80001 Drill Guide for Circular Locking Holes 1

45-35015 Screwdriver Blade, AO, T10 2

45-85000 Screwdriver Handle, Revolving/Rigid, AO 2

45-35030 Holding Sleeve for 3.5mm screws 1

45-80010 Plate Bending Pliers 2

45-80020 K-Wire Cutting Pliers (max 1.6mm) 1

64-20129 Forceps with Grasping Lips 1

20


Quantity per REF Description Set

Distal Fibula Additional Instruments

45-27020(S) Overdrill for 2.7mm Screws, AO Fitting optional

45-35020(S) Overdrill for 3.5mm Screws, AO Fitting 2

45-80040(S) Countersink for Screws ø2.7/3.5mm, AO Fitting 1

45-80003 Drill Guide for 3.5mm Independant Lag Screw 1

29-31460 Instrument / Accessory Tray 1

29-31008 Customizable Screw Rack without Markers optional

29-31009 Screw Rack with Markers* optional

29-31001 VariAx Distal Fibula Plate Module incl. Lid 1

29-50000 Generic Inlay 1

Optional Instruments

45-80030 Joint Distraction Forceps optional

45-80300(S) Steinmann Pin, Smooth, 2.5mm x 100mm optional

29-13462 Accessory Tray optional

29-31014 Lid for VariAx Distal Fibula optional Plate Module (spare part)

45-90001 X-Ray Template optional

702926 Repositioning Forceps with Points optional

702932 Repositioning Forceps with Serrated Jaws optional

702944 Repositioning Forceps with Ballspike optional

702936 Mantis Tongs Forceps - King optional

700151 Hook optional

700664 Hohmann Retractor 6mm optional 700665 Hohmann Retractor 8mm optional 700667 Hohmann Retractor 15mm optional

45-35002 VariAx Depth Gauge for 3.5mm Screws, black optional

Note:

* Preconfigured screw rack for VariAx Fibula Locking Plate System with 3.5mm Locking and Non-Locking Screws. See configuration of screws on page 17.

21


REF Description

Screw markers

52-00010 Screw Length Marker for 10mm

























22

Ordering Information - Cases & Trays


Modules And Trays

29-35000 Sterilization Container, 3 levels 1 0

29-13009 Sterilization Container, 4 levels 0 1

29-35200 Stryker Foot Container Lid - Half Size 1 1

29-31400 VariAx Foot Instrument Tray 1 1

29-31007 Drawer for Screw Racks 0 1

29-31000 Deluxe Plate Module (includes Lid) 0 1

29-31021 Inlay for Recon and Trauma Plates 0 1

29-31022 Inlay for Calcaneus Plates 0 1

29-31004 Screw Rack for 3.5 Locking Screws (includes Lid) 0 1

29-31005 Screw Rack for 3.5 Bone Screws (includes Lid) 0 1

29-31050 Basic Plate Module (includes Lid) 1 0

29-31052 Inlay 1 for Basic Plate Module 1 0

29-31053 Inlay 2 for Basic Plate Module 1 0

29-50000 Inlay Generic 0 1

Miscellaneous

45-80000 Spring for Holding Sleeve 0 0

29-31013 Lid for Screw Rack 0 0

29-31012 Lid for Deluxe Plate Module 0 0

29-31051 Lid for Basic Plate Module 0 0

23

This document is intended solely for the use of healthcare professionals. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. The information presented in this brochure is intended to demonstrate a Stryker product. Always refer to the package insert, product label and/or user instructions including the instructions for Cleaning and Sterilization (if applicable) before using any Stryker products. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Stryker, SmartLock and VariAx.

All other trademarks are trademarks of their respective owners or holders. The products listed above are CE marked.

Literature Number: 90-07810LOT B5209

Copyright © 2010 Stryker

Stryker Leibinger GmbH & Co. KGBötzinger Strasse 41D-79111 FreiburgGermany

www.osteosynthesis.stryker.com

variax fibula locking plate system - kategorizacia.mzsr.sk

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