MAUDE Adverse Event Report: Stryker GmbH Gamma3 - Trochanteric Nail Kit, Ti D11x180mm x 125deg; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31251180S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Limb Fracture (4518)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury

• Brand Name: Gamma3 - Trochanteric Nail Kit, Ti D11x180mm x 125deg
• 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: 50934363
• Report Number: 0008031020-2026-01636
• Device Sequence Number: 9509193
• Product Code: HSB
• UDI-Device Identifier: 04546540375070
• UDI-Public: 04546540375070
• Combination Product (Y/N): N
• Initial Reporter State: Ti
• Initial Reporter Country: SZ
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: Lay User/Patient
• Device Catalogue Number: 31251180S
• Device Lot Number: K10B7F8
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown