MAUDE Adverse Event Report: STRYKER GMBH T2 ALPHA FEMUR ANTEGRADE - FEMORAL NAIL GT, LEFT D10X380MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23311038S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "about two months after the initial surgery, the patient experienced pain and visited the hospital, where it was found that the nail had fractured.At that time, a fracture of the trochanteric region was also observed.Revision surgery is planed at (b)(6) 2026.".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.

• Brand Name: T2 ALPHA FEMUR ANTEGRADE - FEMORAL NAIL GT, LEFT D10X380MM
• 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 ; 2018315000
• MDR Report Key: 24151804
• Report Number: 0008031020-2026-00084
• Device Sequence Number: 8969416
• Product Code: HSB
• UDI-Device Identifier: 07613327289589
• UDI-Public: (01)07613327289589(11)240820(17)340731(10)K1D002A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 23311038S
• Device Lot Number: K1D002A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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: 70 YR
• Patient Sex: Male
• Patient Race: Asian