MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø12X320MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23331232S
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, during surgery of an unstable proximal femur case, a sub trochanteric fracture occurred during nail insertion.The surgeon then replaced it with a gamma3 long nail that had been placed in the hospital.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.
Additional Manufacturer Narrative
Correction - please refer to to d4 lot # and h6 (device & method) codes.The reported event could not be confirmed, since the affected device was not returned and other evidence were not shared for evaluation.A device inspection was not possible since the affected device was not returned.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More information such as patient medical records must be available in order to determine the root cause of the issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported, during surgery of a unstable proximal femur case, a sub trochanteric fracture occurred during nail insertion.The surgeon then replaced it with a gamma3 long nail that had been placed in the hospital.

• Brand Name: FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø12X320MM
• 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: 20925384
• Report Number: 0009610622-2024-00954
• Device Sequence Number: 5068556
• Product Code: HSB
• UDI-Device Identifier: 07613327286076
• UDI-Public: (01)07613327286076(17)330430(10)K13C665
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203819
• 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
• Report Date (Section B): 04/30/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 23331232S
• Device Lot Number: K13C665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2023
• 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: 70 YR
• Patient Sex: Female