TRUMATCH®

Personalized Solutions Shoulder SystemSurgical Technique

Surgical Technique TRUMATCH® Personalized Solutions Shoulder System DePuy Synthes 3

Contents

Introduction 4

Indications and Contraindications 5

TRUMATCH® Shoulder Guide Design Features 6

TRUMATCH Shoulder Bone Model Design Features 7

TRUMATCH Shoulder Guide Glenoid Preparation 8

TRUMATCH Shoulder Guide - Guide Placement and Pinning 9

4 DePuy Synthes TRUMATCH® Personalized Solutions Shoulder System Surgical Technique

This brochure is presented to demonstrate a surgical technique. The manufacturer of this device does not practice medicine and cannot recommend this or any other surgical technique for use on a specific patient.

The choice of the appropriate surgical technique is the responsibility of the surgeon performing the operation.

See package insert for a complete listing of indications, contraindications, warnings and precautions.

Introduction

Surgical Technique TRUMATCH® Personalized Solutions Shoulder System DePuy Synthes 5

INDICATIONS

The TRUMATCH® Personalized Solutions Shoulder System is intended to be used as a surgical instrument to assist in the intra-operative positioning of glenoid components used with anatomic and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on pre-operative CT-imaging scans.

The TRUMATCH Personalized Solutions Shoulder System can be used in conjunction with the GLOBAL™ APG+ Shoulder System, the GLOBAL™ STEPTECH® APG Shoulder System, the DELTA XTEND™ Reverse Shoulder System and their respective components.

The TRUMATCH Personalized Solutions Shoulder System guide is single use only.

MATERIAL: Polyamide

Indications and Contraindications

CONTRAINDICATIONS

Patients with conditions or diseases that affect bony landmark recognition.

The SurgiCase Shoulder Planner may restrict use of the TRUMATCH Personalized Solutions Shoulder System Guide when placement of the pilot wire is not optimal for implant placement. To ensure safety and effectiveness of the TRUMATCH Personalized Solutions Shoulder System Guide, the SurgiCase Shoulder Planner restricts the placement of the pilot wire within the intersection of two cones - a 45° cone from the neutral axis and a 60° cone from the normal of the glenoid face.

Any active infection of the surgical area where the surgery will be performed is a contraindication for TRUMATCH Personalized Solutions Shoulder System Guide.

*

6 DePuy Synthes TRUMATCH® Personalized Solutions Shoulder System Surgical Technique

The TRUMATCH Shoulder Guide is an ergonomically-designed, glenoid guide designed to fit on the patient anatomy that provides accuracy of implant placement to improve alignment and surgical outcome.

1. Coracoid Clip: Grips on to the base of coracoid.

2. Fixation K-wire Hole: Provides the option to pin a K-wire (diameter between 1.0 mm and 1.5 mm) for added guide stability during drilling.

3. Push or Directional Handle: Provides haptic or “sensorial touch” feedback and guide seating stability.

4. Central 2.5 mm Pin Hole: Facilitates the planned center hole drilling when using the 2.5mm glenoid pin.

5. Patient Specific Guide Identifier: Alphanumeric code that links the guide to the patient case.

6. Labrum Offset: Bridges between the coracoid clip and the lateral body of the guide to prevent soft tissue interference at the antero-superior border of the glenoid surface.

TRUMATCH® Shoulder Guide Design Features

1

5

6

2

2

3

4

4

4

1

Surgical Technique TRUMATCH® Personalized Solutions Shoulder System DePuy Synthes 7

7. Fixation K-wire Entry Hole: Matches and references the (optional) K-wire fixation and entry point.

8. Central 2.5 mm Pin Entry Hole: Matches and references the planned glenoid pin hole position.

9. Fixation K-wire Exit Hole.

10. Central 2.5 mm Pin Exit Hole.

The TRUMATCH Shoulder Bone Model has been developed to represent the patient’s glenoid anatomy that is used as a reference for the implant placement or in conjunction with the TRUMATCH Shoulder Guide.

TRUMATCH Shoulder Bone Model Design Features

7

8

10

9

8 DePuy Synthes TRUMATCH® Personalized Solutions Shoulder System Surgical Technique

Follow the appropriate Total Anatomic or Reverse Shoulder Implant Surgical Technique for patient positioning, surgical approach and exposure techniques leading up to the exposure of the glenoid.

After following the appropriate surgical technique for exposure, prepare the scapula for the TRUMATCH Personalized Solutions Shoulder System Guide. Each guide is designed to match securely to the patient’s neck of the coracoid process. Take care to completely remove all soft tissue from the neck of the coracoid process.

Remove all soft tissue around the lateral face of the coracoid and obtain hemostasis.

Since the guide fits around the coracoid and anterior glenoid face, avoid placing anterior retractors immediately around the coracoid. Place an anterior glenoid retractor at the lower half of the glenoid so as to not interfere with the access to the coracoid.

Perform a 360° glenoid release by releasing the glenohumeral ligaments, capsule, and labrum necessary to gain complete visualization of the glenoid.

Trumatch Shoulder Guide Glenoid Preparation

Surgical Technique TRUMATCH® Personalized Solutions Shoulder System DePuy Synthes 9

The TRUMATCH Personalized Solutions Shoulder System Guide is designed to fit the patient’s glenoid anatomy. The mating surface of the glenoid face and the coracoid neck should be cleared of soft tissue and dried as much as possible to assure a stable guide fit. Do not remove osteophytes or alter the glenoid bony anatomy before securing the TRUMATCH Personalized Solutions Shoulder System Guide. Do not damage the bony surface where the TRUMATCH Personalized Solutions Shoulder System Guide makes contact with the patient’s glenoid anatomy.

Compare the fit and position of the TRUMATCH Personalized Solutions Shoulder System Guide on the bone model to the planned fit and position on the patient’s glenoid anatomy. The guide’s fit and position on the bone model should match its fit and position on the patient’s glenoid anatomy.

The central glenoid pin diameter is 2.5 mm for the TRUMATCH implant systems.

NOTE: DO NOT USE THE TRUMATCH Personalized Solutions Shoulder System Guide if it is not possible to place the guide in a stable position on the patient’s glenoid anatomy as the instability can negatively impact the guide’s ability to transfer the pre-operative plan. In the event the guide cannot be used, please follow the standard surgical technique.

NOTE: Do not alter the TRUMATCH Personalized Solutions Shoulder System Guide before use. Doing so could generate debris which could contaminate the operating region. In addition, altering the guide could compromise its fit to the patient’s glenoid anatomy.

Make sure the TRUMATCH Personalized Solutions Shoulder System Guide maintains its position on the fitting surface during drilling. Verify that the correct glenoid pin diameter is being used which corresponds to the guide’s glenoid pin cylinder diameter. Do not modify the drill direction by drilling through the glenoid pin cylinder’s surface.

Trumatch Shoulder Guide - Guide Placement And Pinning

11 DePuy Synthes TRUMATCH® Personalized Solutions Shoulder System Surgical Technique

Secure the TRUMATCH Personalized Solutions Shoulder System Guide onto the patient’s glenoid anatomy by seating the coracoid clip on to the base of the coracoid and verify that the base of the glenoid pin cylinder is contacting or seated on the glenoid face.

There is approximately 1 - 2 mm of clearance between the bottom of the labrum offset on the guide and the superior glenoid rim. Avoid excessive downward pushing of the TRUMATCH Personalized Solutions Shoulder System Guide. Make sure critical anatomic structures are not damaged during the guide attachment.

Apply and maintain pressure on the directional/push handle of the TRUMATCH Personalized Solutions Shoulder System Guide to keep contact between the guide and underlying glenoid anatomy during drilling.

TRUMATCH Shoulder Guide Guide Placement and Pinning

Verify full surface contact is achieved between the TRUMATCH Personalized Solutions Shoulder System Guide and the underlying glenoid anatomy with the exception of the 2 mm offset over the superior glenoid ridge. Check for gaps between the guide and the glenoid anatomy to ensure a proper fit.

An optional K-wire (with a diameter between 1.0 mm

and 1.5 mm) may be used to affix the TRUMATCH Personalized Solutions Shoulder System Guide to the glenoid using the fixation K-wire hole.

Surgical Technique TRUMATCH® Personalized Solutions Shoulder System DePuy Synthes 11

TRUMATCH Shoulder Guide Guide Placement and Pinning

Once the TRUMATCH Personalized Solutions Shoulder System Guide is seated properly, apply pressure to the directional handle and drill the central glenoid pin using the appropriate pin with 2.5 mm diameter.

Confirm the guide fit prior to and after drilling for added measure. The central pin hole is used to position the central glenoid pin of the reamer. Do not remove the central glenoid pin from the bone. During drilling, irrigate to reduce heat and any debris generated.

NOTE: Make sure the TRUMATCH Personalized Solutions Shoulder System Guide maintains its position on the fitting surface during drilling. Verify that the correct K-wire diameter is being used which corresponds to the guide’s K-wire cylinder diameter. Do not modify the drill direction by drilling through the K-wire cylinder’s surface.

Remove the optional K-wire before removing the guide.

Remove the TRUMATCH Personalized Solutions Shoulder System Guide. The guide can slide over the central glenoid pin. Take care not to alter the direction of the central glenoid pin while removing the guide.

Should it be too difficult to remove the guide over the central glenoid pin without modifying the direction of the central glenoid pin, remove the central glenoid pin, then remove the guide and reinsert the central glenoid pin very carefully in the pre-drilled hole in the bone.

Follow the appropriate Implant Surgical Technique to complete the steps required to finalize the glenoid preparation for the prosthesis.

NOTE: During reaming, do not violate a substantial amount of subchondral cortical bone as this has been shown to be associated with subsidence of the glenoid component.

© DePuy Synthes 2018. All rights reserved. 094522-200608 EMEA

DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46582USATel: +1 (800) 366-8143Fax: +1 (800) 669-2530

Materialise NVTechnologielaan 153001 LeuvenBelgiumTel: +1 (734) 259-6669DPSservice@materialise.be

DePuy Ireland UCLoughbeg, RingaskiddyCo. Cork, IrelandTel: +35 (321) 491 4000Fax: +35 (321) 491 4199

www.jnjmedicaldevices.com

Distributed By: Manufactured By:

The third-party trademarks used herein are the trademarks of their respective owners.

For full product details and precautions, please consult the IFU.