MAUDE Adverse Event Report: Stryker GmbH GAMMA3 - LONG NAIL KIT R1.5, TI, RIGHT D11X380MM X 125DEG; Rod, Fixation, Intramedullary And Accessories

Catalog Number	34251380S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "a (b)(6) patient, initially treated on (b)(6) 2026.No implantation errors detected; nail fracture at a body weight of approximately 70 kg as early as (b)(6), i.E.Barely 8 weeks post-operation.Revision surgery with a prosthesis".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "a 95-year-old patient, initially treated on (b)(6) 2026.No implantation errors detected; nail fracture at a body weight of approximately 70 kg as early as (b)(6), i.E.Barely 8 weeks post-op.Revision surgery with a prosthesis".
Additional Manufacturer Narrative
Correction: please note that the initial report was sent on an incorrect fda registration number.This report should be registered for fda registration number 0008031020 - te (selzach).The reported event could be confirmed based on the device inspection and the provided images.The device inspection revealed the following: the received nail is broken in the webs of the lag screw hole.The breakage surface exhibits clear signs of a fatigue fracture.Fatigue zones with a smooth surface and 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.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.The event and provided documentation was forwarded to medical affairs, with the following review: « unfortunately, the distal images are missing, we don¿t know how it was locked distally.Additionally it is interesting to know whether proximally the lag screw was locked statically or dynamic.The breakage can have too many reasons, a lot of remaining instability in the fracture causing too much movement in the junction.This can also be combined with misdrilling which could have weakened the nail.We cannot be definitive about both without having all the facts.The location and pattern of the fracture, biology, and the technical aspects of the surgical procedure may 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.The broken nail was returned for evaluation and no product related issue could be detected.The evaluation of the nail has shown that fatigue caused by high loads did lead to the breakage of the device.However, as noted by medical affairs, although both patient and procedural factors may have played a role, this cannot be definitively established based on the information provided.As a result, the root cause remains undetermined.If more information is provided, the case will be reassessed.

• Brand Name: GAMMA3 - LONG NAIL KIT R1.5, TI, RIGHT D11X380MM 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: 25521165
• Report Number: 0009610622-2026-00002
• Device Sequence Number: 13303260
• Product Code: HSB
• UDI-Device Identifier: 07613252273844
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200869
• 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,Followup
• Report Date (Section B): 09/22/2026

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: 34251380S
• Device Lot Number: K118B22
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/30/2026
• 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: 05/19/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• 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 Sex: Male
• Patient Weight: 154 LB