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 Code	Insufficient Information (4580)
Date of Event	08/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "gamma3 nail fracture in the area of the shs.The implant is no longer available.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
Correction: please refer to section h6 (method code).The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "gamma3 nail fracture in the area of the shs.The implant is no longer available.".
Event or Problem Description
As reported: "gamma3 nail fracture in the area of the shs.The implant is no longer available.".
Additional Manufacturer Narrative
Corrections: please refer to sections d9 the device was returned and h6 (method and results codes).The reported event could be confirmed since the device was returned for evaluation and matches the alleged event.The returned device underwent a detailed visual examination, which revealed that it had fractured into two distinct fragments across the webs of the lag screw.Prominent misdrilling marks were observed on the implant surface, beginning anteriorly and extending toward the lateral aspect of the nail.Such misdrilling introduces a notching effect that significantly contributes to crack initiation and adversely affects the load-bearing capacity of the device.Slight deformation was also noted on both the proximal and distal fragments, consistent with repetitive loading.Microscopic evaluation of the fracture surface showed characteristic features of fatigue failure, including visible arrest lines indicative of progressive crack propagation over time.Additionally, one region of the fracture displayed a shiny appearance consistent with a brittle fracture, suggesting the final catastrophic failure point.Overall, the fracture pattern suggests a multifactorial failure mechanism involving both fatigue and brittle breakage characteristics.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 above investigation, the breakage of nail contributes to multipfactorial fatigue and is brittle in nature.No product related issue could be detected during the performed investigation of the returned device.Regarding the root cause of the implant failure no conclusive statement can be provided, because key clinical information (e.G.X-rays in different planes, clinical status, patient activity, assessment of the treating physician or operation reports) is missing.The root causes in such cases are often complex and multifactorial and cannot be determined scientifically without this decisive evidence.Due to these limitations, we are unable in such cases to provide statements about the patient, the procedure and/or the device in relation to cause of the failure.If more information is provided, the case will be reassessed.

• 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: 23833699
• Report Number: 0008031020-2025-02181
• Device Sequence Number: 9278123
• Product Code: HSB
• UDI-Device Identifier: 04546540375087
• UDI-Public: (01)04546540375087(17)30131(10)K1021CB
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200869
• 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,Followup
• Report Date (Section B): 03/24/2026

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: K1021CB
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 02/23/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/09/2026; 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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: Unknown