MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - TROCHANTERIC NAIL 170MM D12X170MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81252170S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Necrosis (1971); Perforation (2001)
Date of Event	09/08/2025
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: "the lag screw cut out.The patient had been following instructions.However, this time it was traumatic avascular necrosis caused by a fall.The event was discovered on (b)(6) 2025 and the nail was removed and an artificial head was implemented on (b)(6) 2025.".
Event or Problem Description
As reported: "the lag screw cut out.The patient had been following instructions.However, this time it was traumatic avascular necrosis caused by a fall.The event was discovered on (b)(6) 2025, and the nail was removed and an artificial head was implemented on (b)(6) 2025.".
Additional Manufacturer Narrative
The device has not been returned.The lag screw cut out could be confirmed by x-ray image received.The images show that the femoral had and neck collapsed over the system.Based on investigation, the root cause was attributed to a patient related issue.The patient fall led to a avascular necrosis, which ultimately caused the lag screw cut out.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: GAMMA4 - TROCHANTERIC NAIL 170MM D12X170MM 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 KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23219834
• Report Number: 0008031020-2025-01666
• Device Sequence Number: 13219047
• Product Code: HSB
• UDI-Device Identifier: 07613327479348
• UDI-Public: (01)07613327479348(17)340131(10)K196FE0
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: 81252170S
• Device Lot Number: K196FE0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2024
• 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 Age: 88 YR
• Patient Sex: Female