MAUDE Adverse Event Report: Stryker GmbH T2 Alpha Femur Retrograde - Femoral Nail Retrograde D11x280mm; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23391128S
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The implant that was scheduled for use had not been arranged.The patient waited for it to arrive under anaesthesia for three hours.Then, the procedure was completed with any issues.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: T2 Alpha Femur Retrograde - Femoral Nail Retrograde D11x280mm
• 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: 50089442
• Report Number: 0008031020-2026-00931
• Device Sequence Number: 15906722
• Product Code: HSB
• UDI-Device Identifier: 07613327293890
• UDI-Public: (01)07613327293890(17)351231(10)K1892BC
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K253640
• 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): 09/03/2026

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 Catalogue Number: 23391128S
• Device Lot Number: K1892BC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/03/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2026
• 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: Other
• Patient Sex: Female