MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - TROCHANTERIC NAIL KIT, TI D11X200MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31251200S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Insufficient Information (4580)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the customer called to report a broken gamma 3 nail.Implantation date: (b)(6) 2025.Planned revision: scheduled for (b)(6) 2025".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed based on the device inspection and the provided images.The device inspection revealed the following: the nail is broken at the level of the lag screw hole.The breakage surface exhibits clear signs of a fatigue fracture.Fatigue zones with a smooth surface and clear progression lines are visible.Material deformation can be seen on the edge of the hole on the distal end which most likely had created the starting point of the fracture at lateral.This most probably comes from high compressive load, indicating the nail was exposed to continuous high load over a longer period of time.Altogether, the fracture pattern is characteristic of a fatigue failure.The nail likely fractured progressively due to high tension and loading over time, before ultimately failing.The event and provided documentation was forwarded to medical affairs, with the following review: the nail broke after 3 months, using a short nail for this fracture type is usually not considered to be sufficient.These fractures are particularly tricky because of the lack of stability in the proximal part, which causes continuous movement between the fracture parts and in the end will lead to failure if bone healing is not fast enough.There is little callus formation after 3 months.Based on the investigation, the breakage of the implant happened in a fatigue manner by application of continuous high load overtime.The exact root cause cannot be defined as non-unions are, in general, multifactorial.The location and pattern of the fracture, biology, and the technical aspects of the surgical procedure have contributed to the event.Furthermore, patient activity levels post-op may also have contributed to an inadequate load distribution and, therefore, the breakage of the implant.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.Based on the investigation, the root cause was attributed to a combination of user and patient condition related issue.The implant breakage occurred as a result of the bone non-union.The choice of the construct and technical aspects of the procedure may also have contributed to the non-union, and therefore failure of the implant.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the customer called to report a broken gamma 3 nail.Implantation date: (b)(6) 2025 planned revision: scheduled for (b)(6) 2025.".

• Brand Name: GAMMA3 - TROCHANTERIC NAIL KIT, TI D11X200MM 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: 23639533
• Report Number: 0008031020-2025-02105
• Device Sequence Number: 9259143
• Product Code: HSB
• UDI-Device Identifier: 04546540375087
• UDI-Public: (01)04546540375087(17)300331(10)K11715A
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 31251200S
• Device Lot Number: K11715A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female