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TORNIER AEQUALIS REV II Threaded Post Baseplate SURGICAL TECHNIQUE ADDENDUM

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Page 1: TORNIER AEQUALIS REV II€¦ · Note: 4, 5 and 6 mm drill bits are available for gradual preparation of the central hole, if desired. (Figure 6) The first drill bit is used over the

TORNIER

AEQUALIS REV IIThreaded Post Baseplate

SURGIC AL TECHNIQUE ADDENDUM

Page 2: TORNIER AEQUALIS REV II€¦ · Note: 4, 5 and 6 mm drill bits are available for gradual preparation of the central hole, if desired. (Figure 6) The first drill bit is used over the

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Page 3: TORNIER AEQUALIS REV II€¦ · Note: 4, 5 and 6 mm drill bits are available for gradual preparation of the central hole, if desired. (Figure 6) The first drill bit is used over the

Overview/Intended Use ...................................................................................................................................... 4

Guide Pin Positioning ......................................................................................................................................... 4

Glenoid Depth Evaluation .................................................................................................................................. 5

Reaming .................................................................................................................................................................. 5

Central Hole Drilling ............................................................................................................................................ 6

Depth Gauge.......................................................................................................................................................... 6

Counterbore Drill .................................................................................................................................................. 7

Tapping ................................................................................................................................................................... 7

Introduction of the Baseplate .......................................................................................................................... 8

Peripheral Screw Drilling ................................................................................................................................... 9

Peripheral Screw Fixation ................................................................................................................................10

Sphere Fixation ...................................................................................................................................................10

Instrumentation ..................................................................................................................................................11

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Table of Contents:

Page 4: TORNIER AEQUALIS REV II€¦ · Note: 4, 5 and 6 mm drill bits are available for gradual preparation of the central hole, if desired. (Figure 6) The first drill bit is used over the

Guide Pin Positioning

All steps prior to the positioning of the guide pin should be followed as they are described in the AEQUALIS Reversed II surgical technique. The 2.5 x 200 mm guide pin should be positioned as described in the AEQUALIS Reversed II surgical technique. (Figure 1)

Overview

This technique contains instructions for the use of the Threaded Post Baseplate, which is an expanded offering of the AEQUALIS™ Reversed II product family. The Threaded Post Baseplate is an alternative to the existing AEQUALIS Reversed II press-fit baseplate. The surgeon has to evaluate the bone quality preoperatively in order to decide if he uses the Threaded Post Baseplate or the Press Fit Baseplate.

Intended Use

Please refer to the AEQUALIS Reversed II surgical technique for a complete list of indications.

Figure 1

Surgical Steps

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Note: It is recommended to stop drilling as soon as the far cortex is reached in order to produce an accurate depth measurement in the following step. Direct palpation of the guide pin tip is recommended to confirm the pin is exiting the anterior cortex and ensure the tip is barely protruding for an accurate length measurement in subsequent steps.

Page 5: TORNIER AEQUALIS REV II€¦ · Note: 4, 5 and 6 mm drill bits are available for gradual preparation of the central hole, if desired. (Figure 6) The first drill bit is used over the

Glenoid Depth Evaluation

Once the pin is in place, the length of the pin inside the scapula is evaluated using the pin gauge. The pin gauge is slid over the 2.5 mm guide pin and the length of the pin inside the scapula is read using the end of the pin as a measurement marker to indicate the depth. (Figure 2)

This evaluated length is an indication for the correct position of the pin. The desired position is slightly anterior, so that the threaded post can exit with its tip through the anterior cortical wall to ensure cortical fixation is achieved.

It is recommended to reposition the pin anteriorly when the evaluated depth is significantly longer than 35 mm and repositioned posteriorly when it is significantly shorter than 25 mm. This will ensure that cortical fixation is achieved at the tip of the screw.

Reaming

The glenoid is then reamed over the guide wire with the corresponding baseplate reamer (Ø25 mm or Ø29 mm) and peripheral reamer (Ø36 mm or Ø42 mm) as described in the AEQUALIS™ Reversed II surgical technique. (Figure 3)

Figure 3

Figure 2

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Note: Standard baseplates are available in 30 and 35 mm post lengths. Baseplates with post lengths above or below these sizes are available upon request only.

Page 6: TORNIER AEQUALIS REV II€¦ · Note: 4, 5 and 6 mm drill bits are available for gradual preparation of the central hole, if desired. (Figure 6) The first drill bit is used over the

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Figure 7

Note: To ensure an accurate evaluation of the final implant length, make sure the tip of the depth gauge is contacting the glenoid surface. Positioning the tip of the depth gauge inside hole will result in an incorrect evaluation.

Note: 4, 5 and 6 mm drill bits are available for gradual preparation of the central hole, if desired. (Figure 6) The first drill bit is used over the initial guide pin. Increasing diameter drills are used until the final 6.5 mm drilling step is performed.

Central Hole Drilling

The glenoid central hole is drilled over the guide wire using the cannulated Ø6.5 mm drill bit. Laser marks can be used to help determine the final implant length. (Figure 4) Palpation of the drill bit tip can be performed to confirm the drill bit has exited the cortex.

The drilling is performed under power over the guide wire. The drill depth depends on the previously evaluated pin depth: (Figure 5)

• If the pin depth evaluation is 25 mm or shorter, the drilling should continue until the drill penetrates the cortical wall to ensure the 30 mm threaded post can be fully inserted.

• If the pin depth is between 25 mm and 30 mm, the drilling should advance to at least 30 mm or until the drill exits the cortex. This will appropriately prepare the glenoid to receive the 30 mm length baseplate.

• If the pin depth is over 30 mm, the drilling should advance to at least 35 mm or until the drill exits the cortex. This will appropriately prepare the glenoid to receive the 35 mm length baseplate.

Depth Gauge

If additional evaluation of the final implant length is required, the peripheral screw hole depth gauge can be used. (Figure 7)

Figure 4

Figure 5

Figure 6

253035404550

Page 7: TORNIER AEQUALIS REV II€¦ · Note: 4, 5 and 6 mm drill bits are available for gradual preparation of the central hole, if desired. (Figure 6) The first drill bit is used over the

Counterbore Drill

The starter hole is expanded using the cannulated Ø8.2 mm counterbore drill bit under power. (Figure 8) If the pin is removed during the previous step, the drill is centered on the previous hole and performed free-hand. This will prepare the bone for the coated post section of the implant. Drilling should progress until the positive stop reaches the glenoid surface.

Tapping

After drilling the central hole, the guide pin is removed and the tap is used in order to prepare the threads of the final implant.

Similar to the drill bit, there are depth laser markings on the tap. The tapping depth should be chosen similar to the depth of the drilled central hole.

A depth stop can be placed at the desired position in order to stop the tapping at the desired depth. (Figure 9)

For post lengths 25, 30, 35 and 40 mm, stop at the level of the corresponding laser mark. For lengths 45 mm and 50 mm stop at the level of the step on the tap, shown on Figure 9.

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Figure 9

Figure 8

Note: The tap stopper can be “Clicked” to the next position, so it is important to stop once the tap stop is flush with the glenoid surface. (Figure 10) The tap stopper is not needed for 45 and 50 mm tapping.

Note: When tapping, it is important to maintain alignment to the axis of the previously drilled hole.

Note: Tapping has to be done manually using the AEQUALIS™ Reversed II handle (Do not use with power).

Shown with depth stop

Shown without depth stop35

40

30

25303540

Figure 10

Note: Tapping is mandatory in order to prevent glenoid fracture.

Page 8: TORNIER AEQUALIS REV II€¦ · Note: 4, 5 and 6 mm drill bits are available for gradual preparation of the central hole, if desired. (Figure 6) The first drill bit is used over the

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Note: The baseplate should be seated completely onto the prepared glenoid surface. Use three finger tightening technique to avoid over-tightening or excessive advancement of the baseplate into the subchondral bone.

Gaps between the baseplate and glenoid surface should also be avoided.

Introduction of the Baseplate

The final baseplate is chosen according to the prepared hole (30 or 35 mm for standard implant) and the reamed glenoid surface (Ø25 mm or Ø29 mm).

The glenoid baseplate is attached to the baseplate holder through its central hole using a screw in the central shaft of the handle. Care should be taken to ensure that the two pegs on the impactor seat properly into their respective holes on the implant baseplate. (Figure 11)

The baseplate is carefully threaded into the prepared hole. It is important to continuously check the orientation of the baseplate relative to the prepared hole and reamed surface to ensure accurate implantation of the baseplate. (Figure 12)

Once the baseplate is seated flush on the glenoid surface (Figure 13), the baseplate holder is detached from the baseplate.

Figure 11

Figure 12

Figure 13

Page 9: TORNIER AEQUALIS REV II€¦ · Note: 4, 5 and 6 mm drill bits are available for gradual preparation of the central hole, if desired. (Figure 6) The first drill bit is used over the

+/-20°Note: It is important to avoid angling the drill guide and drill too close to the post in order to avoid any damage to the post and compromising fixation.

The screw length is read directly on the drill guide by locating the laser mark on the drill through the window on the drill guide. (Figure 16) If desired, a standard depth gauge is available.

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Peripheral Screw Drilling

Once the baseplate is implanted, the 4 peripheral holes are prepared using the Ø3 mm drill bit and the locking screw drill guide from the Reversed II instrumentation. (Figure 14a)

All 4 holes of the threaded post baseplate are multidirectional locking screws and can be angled up to 20° away from the central post and 0° toward the post. The screws can also be angled +/-20° parallel to the post. (Figure 14b) The direction of the drill axis is chosen by free orientation of the drill guide. The Ø3 mm drill bit is passed through the guide and the hole is drilled bicortically. (Figure 15)

It is desirable to have the superior screw in the base of the Coracoid and the inferior screw in the pillar of the Scapula, where the best bone fixation of the screws can be achieved.

Figure 14a

Figure 14b

Figure 15

50 45 40 35 30 25 20

Figure 16

Page 10: TORNIER AEQUALIS REV II€¦ · Note: 4, 5 and 6 mm drill bits are available for gradual preparation of the central hole, if desired. (Figure 6) The first drill bit is used over the

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Peripheral Screw Fixation

After drilling each hole, the measured screws are inserted into the drilled hole and fully tightened with the 4.5 mm screwdriver. (Figure 17) The baseplate implantation is finalized once all screws are seated. (Figure 18)

Sphere Fixation

After implantation of the baseplate and screws, the sphere is impacted and screwed into the threaded post baseplate using the same technique described in the AEQUALIS™ Reversed II surgical technique. (Figure 19)

All AEQUALIS™ Reversed II spheres are compatible with the threaded post baseplate.

Figure 17

Figure 19

Figure 18

Note: The threaded post baseplate contains 2 mm of lateral offset, therefore, there is always a gap of 2 mm between the sphere and the glenoid surface.

Page 11: TORNIER AEQUALIS REV II€¦ · Note: 4, 5 and 6 mm drill bits are available for gradual preparation of the central hole, if desired. (Figure 6) The first drill bit is used over the

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Standard Implants

Reference Description Quantity

DWE730 Ø25 x 30 mm 1

DWE735 Ø25 x 35 mm 1

DWE830 Ø29 x 30 mm 1

DWE835 Ø29 x 35 mm 1

Single Use

Reference Description Quantity

DWD063** Ø2.5 mm Alignment Pin L200 mm (Sterile) **

MWF715* Ø2.5 mm Modified Guide Pin (Non-sterile) *

*Upon request only**Included in Rev II Single Use Instruments

Special Order Implants*

Reference Description Quantity

DWE725* Ø25 x 25 mm 1

DWE740* Ø25 x 40 mm 1

DWE825* Ø29 x 25 mm 1

DWE840* Ø29 x 40 mm 1

DWE845* Ø29 x 45 mm 1

*Upon request only

Instrumentation

Threaded Post Baseplate Implants

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Reference Description Quantity

MWF713 Pin Gauge 1

MWF711 Drill Bit Dia. 6.5 1

MWF709 Drill Bit Dia. 8.2 1

MWF714 Tap 1

MWF716 Tap Depth Stop 1

MWF717 Drill Bit Dia. 4 mm 1

MWF718 Drill Bit Dia. 5 mm 1

MWF719 Drill Bit Dia. 6 mm 1

MWF710 Baseplate Holder 1

Ref: YKAD987

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Cobalt Chrome

Reference Description Quantity

DWH901 Ø33 mm - 10° Tilted Glenoid Sphere

Ø25 mm

DWH902 Ø33 mm Lateralized +6 mm -

DWH903 Ø33 mm Lateralized +8 Glenoid Sphere

DWD180 Ø36 mm Centered Glenoid Sphere

DWD181 Ø36 mm 10° Tilted Glenoid Sphere

DWD182 Ø36 mm Eccentric + 2 mm Glenoid Sphere

DWH904 Ø39 mm Centered Glenoid Sphere

DWH905 Ø39 mm 10° Tilted Glenoid Sphere

DWH906 Ø39 mm Eccentric + 2 mm Glenoid Sphere

DWD183 Ø42 mm Centered Glenoid Sphere

DWD184 Ø42 mm 10° Tilted Glenoid Sphere

DWD185 Ø42 mm Eccentric + 2 mm Glenoid Sphere

DWD190 or DWB935 Ø36 mm Centered Glenoid Sphere

Ø29 mm

DWD191 Ø36 mm 10° Tilted Glenoid Sphere

DWD192 Ø36 mm Eccentric + 2 mm Glenoid Sphere

DWH907 Ø39 mm Centered Glenoid Sphere

DWH908 Ø39 mm 10° Tilted Glenoid Sphere

DWH909 Ø39 mm Eccentric + 2 mm Glenoid Sphere

DWD193 or DWB936 Ø42 mm Centered Glenoid Sphere

DWD194 Ø42 mm 10° Tilted Glenoid Sphere

DWD195 Ø42 mm Eccentric + 2 mm Glenoid Sphere

Titanium

Reference Description Quantity

DWE860 Ø36 mm Centered Titanium Glenoid Sphere Ø25 mm

DWE880 Ø36 mm Centered Titanium Glenoid Sphere Ø29 mm

DWE890 Ø42 mm Centered Titanium Glenoid Sphere

Glenoid Sphere for Glenoid Baseplate

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Notes

Page 15: TORNIER AEQUALIS REV II€¦ · Note: 4, 5 and 6 mm drill bits are available for gradual preparation of the central hole, if desired. (Figure 6) The first drill bit is used over the

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Notes

Page 16: TORNIER AEQUALIS REV II€¦ · Note: 4, 5 and 6 mm drill bits are available for gradual preparation of the central hole, if desired. (Figure 6) The first drill bit is used over the

Proper surgical procedures and techniques are the responsibility of the medical professional. This material is furnished for information purposes only. Each surgeon must evaluate the appropriateness of the material based on his or her personal medical training and experience. Prior to use of any Tornier implant system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects. Package inserts are also available by contacting Wright. Contact information can be found in this document and the package insert.

™Trademarks and ®Registered marks of Wright Medical Group N.V. or its affiliates.©2016 Wright Medical Group N.V. or its affiliates. All Rights Reserved.

CAW-6411 REV E ECN 160232 11-Feb-2016

10801 Nesbitt Avenue SouthBloomington, MN 55437888 867 6437952 426 7600www.tornier.com

1023 Cherry RoadMemphis, TN 38117800 238 7117901 867 9971www.wright.com