MAUDE Adverse Event Report: STRYKER GMBH T2 ALPHA FEMUR RETROGRADE - FEMORAL NAIL RETROGRADE D10X340MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23391034S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that the implant failed about 3 months post-op.
Additional Manufacturer Narrative
Corrections: h6 (method code), d9 (product return status).The reported event of a failed implant could be confirmed, since the returned nail is broken apart.The device inspection revealed the following: as received condition, the broken nail was returned for evaluation.The breakage at the most proximal distal hole can be confirmed.During the microscopic inspection of the nail fracture face the typical characteristics of a fatigue fracture could be identified on both fracture faces.There is a fatigue zone with a smooth surface and progression lines which ends in a rougher instantaneous zone, where the nail finally broke apart.The visible shiny surfaces were created by the fragments rubbing against each other.There are impression marks from the locking screw in the bore visible.These marks are consistent with high load transfer from the locking screw during continuous weight-bearing.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.No product related issue could be detected during the performed investigation of the returned device.Regarding the root cause of the implant failure no conclusive statement can be provided, because key clinical information (e.G.X-rays in different planes, clinical status, patient information and activity, assessment of the treating physician or operation reports) is missing.The root causes in such cases are often complex and multifactorial and cannot be determined scientifically without this decisive evidence.Due to these limitations, we are unable in such cases to provide statements about the patient, the procedure and/or the device in relation to cause of the failure.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the implant failed about 3 months post-op.

• Brand Name: T2 ALPHA FEMUR RETROGRADE - FEMORAL NAIL RETROGRADE D10X340MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24073089
• Report Number: 0008031020-2026-00038
• Device Sequence Number: 13039896
• Product Code: HSB
• UDI-Device Identifier: 07613327292442
• UDI-Public: (01)07613327292442(17)310831(10)K1D9076
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K250163
• 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): 04/10/2026

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: 23391034S
• Device Lot Number: K1D9076
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• 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: Other
• Patient Sex: Unknown