MAUDE Adverse Event Report: Stryker GmbH T2 FEMUR - FEMORAL NAIL, A/R, R1500 D9X360 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18280936S
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
It was reported that, on (b)(6) 2025, at (b)(6) hospital, a t2 femoral nail was implanted on (b)(6) 2024 which was removed due to bending deformation.This incident was not reported by the surgeon at the time; it is now being reported at the request of the t&e regulatory affairs specialist.Stryker personnel became aware of this event during the notification of a second revision performed on the same patient in (b)(6) 2026.

• Brand Name: T2 FEMUR - FEMORAL NAIL, A/R, R1500 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 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: 25830012
• Report Number: 0008031020-2026-00860
• Device Sequence Number: 16041363
• Product Code: HSB
• UDI-Device Identifier: 04546540200297
• UDI-Public: 04546540200297
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: 18280936S
• Device Lot Number: K0D4E1
• Was Device Available for Evaluation?: No
• 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: 06/18/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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