MAUDE Adverse Event Report: Stryker GmbH Gamma4 - Intermediate Targeting Sleeve; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	14202100
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "on the (b)(6)2026 a g4 intermediate nail has been used at (b)(6) hospital.This case was covered by (b)(6).The distal locking screw through the gamma4 targeted jig missed the nail.This was believed to be corrected at the time by re-attaching the jig and checking on xray.However, at a follow up xray the screw has appeared to miss posteriorly compared to it previously missing anteriorly.This resulted in the patient coming back to theatre on the (b)(6)2026 to have another distal screw inserted through the nail.The jig was re-attached and again when drilling through the intermediate jig the drill was hitting the nail and not aligning with the locking screw hole.The surgeon mateo managed to get a screw through the oblique hole of the intermediate nail and tried again through the static locking.The issue was raised that he believes there may be some issues with the jig itself or the nail screw holes not aligning with the jig correctly if 1 screw is able to pass through but not the other.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.

• Brand Name: Gamma4 - Intermediate Targeting Sleeve
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): Stryker GmbH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): Stryker Trauma GmbH; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50440232
• Report Number: 0008031020-2026-01347
• Device Sequence Number: 15667233
• Product Code: HSB
• UDI-Device Identifier: 07613327591477
• UDI-Public: 07613327591477
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K230512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 14202100
• Device Lot Number: KP505180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male