MAUDE Adverse Event Report: STRYKER GMBH T2 FEMUR - FEMORAL NAIL, A/R D9X360 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18250936S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/09/2025
Type of Reportable Event	Serious Injury
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 trauma patient was treated for a mid-shaft femur fracture with the t2 femoral ar nail implant.The fracture was reduced, and the femur was distally reamed to 10.5mm to accommodate a 9 × 360 mm nail, which was the smallest available size.However, the implant from the hospital¿s consignment inventory had expired on (b)(6) 2025, and a replacement had not yet been received, making it unavailable for use.The surgery time was extended by more that 30 minutes as the team reviewed surgical options and prepared the femur to implant a larger nail.Additional reaming was performed to accommodate a 10 × 360 mm t2 femoral ar nail.".
Additional Manufacturer Narrative
The reported event could be confirmed through the product details mentioned on the product label and surgery date mentioned, as shared in the additional information.The device was received in a perfectly sealed condition and upon reviewing the product label, it could be confirmed that the expiration date has surpassed.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.Information regarding the device, including its expiration date is clearly available on its packaging.Therefore, it is the responsibility of the operating surgeon and the staff to check that before the surgery.Even, if the shelf life is exceeded, it is recommended to re-sterilize the device before use.This is required as per ifu.For the given case, even though the implant was not used for the surgery but the issue is deemed to be user related as it is the responsibility of the surgeon and the staff to inspect the devices prior to the surgery which is required as per ifu.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "a trauma patient was treated for a mid-shaft femur fracture with the t2 femoral ar nail implant.The fracture was reduced, and the femur was distally reamed to 10.5mm to accommodate a 9 × 360 mm nail, which was the smallest available size.However, the implant from the hospital¿s consignment inventory had expired on september 30, 2025, and a replacement had not yet been received, making it unavailable for use.The surgery time was extended by more that 30 minutes as the team reviewed surgical options and prepared the femur to implant a larger nail.Additional reaming was performed to accommodate a 10 × 360 mm t2 femoral ar nail.".

• Brand Name: T2 FEMUR - FEMORAL NAIL, A/R D9X360 MM
• 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: 23759581
• Report Number: 0008031020-2025-02134
• Device Sequence Number: 10079454
• Product Code: HSB
• UDI-Device Identifier: 04546540199386
• UDI-Public: (01)04546540199386(11)201002(17)250930(10)K093C38
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/03/2026

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: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 18250936S
• Device Lot Number: K093C38
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2020
• 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