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	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corrections: please refer to sections d9 the device was returned and h6 (method, results codes).The reported event could be confirmed with the provided x-rays and returned devices; we can confirm that the set screw was not positioned deep enough to prevent lag screw from migration.The device inspection revealed the following: the visual inspection has shown the first contact of the set screw was not inside the groove of the lag screw rather it was at the edge of the groove, a similar impression could be seen at the tip of set screw as well.This indicates that the set screw was not placed deep enough.When set screw is unscrewed a quarter turn from here, it allows for quite a distance for medial migration.Hcp remarks on the provided x rays: the hcp noted that the fracture may not have been adequately reduced, which could have led to fracture collapse and instability.This instability may have caused increased movement between the lag screw and the nail, contributing to medial migration.The hcp also observed that the nail was initially locked with two screws, but a later x-ray showed that the proximal locking screw had been removed, leaving the construct fully dynamized.The reason and timing for removal of this screw are unknown.The hcp stated that if dynamization occurred before the migration event, it may have increased movement at the fracture site and contributed to the observed migration.Overall, the hcp considered several factors to be potentially involved and was unable to identify a single cause for the event.Based on the inspection findings and the hcp assessment, the event appears to be multifactorial.Possible contributing factors include incomplete engagement of the set screw, fracture instability due to inadequate reduction and subsequent fracture collapse, and increased construct mobility following dynamization.As multiple factors may have contributed to the event and key information regarding the clinical timeline is unavailable, a definitive root cause cannot be determined.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.
Event or Problem Description
The following information was reported: medial migrating of the lag screw withing gamma4 intermediate nail.

• 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: 25785150
• Report Number: 0008031020-2026-00838
• Device Sequence Number: 10722016
• Product Code: HSB
• UDI-Device Identifier: 07613327478877
• UDI-Public: (01)07613327478877(11)251020(17)350930(10)K14FA1F
• 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: Company Representative
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 81251170S
• Device Lot Number: K14FA1F
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2026
• 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: 06/15/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2025
• 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
• Patient Sex: Unknown