MAUDE Adverse Event Report: STRYKER GMBH TROCHANTERIC NAIL KIT, TI GAMMA3 Ø11X200MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31251200S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "exactly 4 months previously, the patient had undergone osteosynthesis using a gamma nail as part of a subtrochanteric fracture of the left femur.After an uncomplicated and timely course, the patient then presented to the hospital in an emergency four months later.Radiology revealed a fracture of the gamma nail in the area where the femoral neck screw was inserted.A revision was then performed.The gamma nail was removed and a long stem prosthesis was implanted.Subsequent timely and normal progression.".
Event or Problem Description
As reported: "exactly 4 months previously, the patient had undergone osteosynthesis using a gamma nail as part of a subtrochanteric fracture of the left femur.After an uncomplicated and timely course, the patient then presented to the hospital in an emergency four months later.Radiology revealed a fracture of the gamma nail in the area where the femoral neck screw was inserted.A revision was then performed.The gamma nail was removed and a long stem prosthesis was implanted.Subsequent timely and normal progression.".
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was not returned.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.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.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Additional Manufacturer Narrative
Correction: please refer to section h6 (method, results and clinical signs codes).The implant has not been returned for inspection.X-ray images confirming the fracture and the post-operative nail breakage at the lag screw hole were returned.The reported event could therefore be confirmed.The root cause of the implant breakage could not be determine based only on the images received.The return of the device and medical records of the patient are necessary for a complete investigation.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "exactly 4 months previously, the patient had undergone osteosynthesis using a gamma nail as part of a subtrochanteric fracture of the left femur.After an uncomplicated and timely course, the patient then presented to the hospital in an emergency four months later.Radiology revealed a fracture of the gamma nail in the area where the femoral neck screw was inserted.A revision was then performed.The gamma nail was removed and a long stem prosthesis was implanted.Subsequent timely and normal progression.".

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3 Ø11X200MM X 125°
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21093827
• Report Number: 0009610622-2025-00003
• Device Sequence Number: 9161508
• Product Code: HSB
• UDI-Device Identifier: 04546540375087
• UDI-Public: (01)04546540375087(17)290131(10)K1A33A4
• 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): 06/17/2025

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: K1A33A4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 01/29/2025; 05/20/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/26/2025; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2024
• 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: 83 YR
• Patient Sex: Female