MAUDE Adverse Event Report: Stryker GmbH GAMMA4 - TROCHANTERIC NAIL 170MM D10X170MM X 125DEG; Rod, Fixation, Intramedullary And Accessories

Catalog Number	81250170S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "after the intraoperative nail had been inserted and an x-ray was taken prior to wound closure, a bone fracture was detected; consequently, the short nail had to be removed, the cable wound around it, and the nail replaced with a longer one.Because the cable was used with the long nail, wound was larger than initial.".

• Brand Name: GAMMA4 - TROCHANTERIC NAIL 170MM D10X170MM 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: 25618467
• Report Number: 0008031020-2026-00786
• Device Sequence Number: 16006881
• Product Code: HSB
• UDI-Device Identifier: 07613327479058
• UDI-Public: (01)07613327479058(17)350930(10)K14DEAC
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• 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,Followup
• Report Date (Section B): 10/01/2026

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: 81250170S
• Device Lot Number: K14DEAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2025
• 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: Other
• Patient Sex: Unknown