MAUDE Adverse Event Report: STRYKER GMBH T2 ALPHA FEMUR RETROGRADE - FEMORAL NAIL RETROGRADE D12X340MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23391234S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2025
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
As reported: "an osteosynthesis was performed on (b)(6) 2025 for a supracondylar fracture of the femur.The surgery itself was completed uneventfully, but on (b)(6) 2025, we received information that the nail was fracture.A revision surgery is scheduled to be performed.".
Additional Manufacturer Narrative
The reported event could be confirmed during the investigation.A device inspection was not possible since the affected device was not returned.Post-operative x-ray images were received and the nail breakage after three months of implantation could be confirmed.Based on investigation, the root cause was attributed to a patient related issue.The delayed bone union, likely due to the complexity of the fracture, resulted in implant breakage three months after implantation.While the patient's post-operative behavior may have contributed to the implant failure, no conclusions can be drawn on this matter in the absence of patient records.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation if more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "an osteosynthesis was performed on (b)(6) 2025 for a supracondylar fracture of the femur.The surgery itself was completed uneventfully, but on (b)(6) 2025, we received information that the nail was fracture.A revision surgery is scheduled to be performed.".

• Brand Name: T2 ALPHA FEMUR RETROGRADE - FEMORAL NAIL RETROGRADE D12X340MM
• 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: 23138338
• Report Number: 0008031020-2025-01632
• Device Sequence Number: 8847176
• Product Code: HSB
• UDI-Device Identifier: 07613327292893
• UDI-Public: (01)07613327292893(11)220705(17)320630(10)K02DCB8
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K250163
• 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): 12/11/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 23391234S
• Device Lot Number: K02DCB8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2022
• 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