MAUDE Adverse Event Report: Stryker GmbH Gamma4 - Trochanteric Nail 170mm D11x170mm x 125deg; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81251170S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Perforation (2001)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the patient returned to the hospital from a rehabilitation facility due to pain.Radiographic examination demonstrated cut-out of the shs (sliding hip screw) in a gamma 4 nail.On 08-jun, revision surgery was performed with implantation of a hip endoprosthesis.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.

• Brand Name: Gamma4 - Trochanteric Nail 170mm D11x170mm 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: 50359650
• Report Number: 0008031020-2026-01253
• Device Sequence Number: 10146556
• Product Code: HSB
• UDI-Device Identifier: 07613327478877
• UDI-Public: 07613327478877
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2026

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: 81251170S
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• 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
• Patient Weight: 143 LB