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

Catalog Number	23331038S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "during drilling for the proximal reconstruction screw, the distal drill was advanced through the device but struck the nail's screw hole, preventing normal passage." the surgery was completed using a free-hand technique.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.It is worth noting the targeting devices were confirmed as fully functional at the distribution center in japan as well as during the pre-operative testing.Therefore, any issue linked to the targeting devices themselves is excluded.However, this gives no indication regarding the intra-operative positioning of the nail itself: more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Misalignment with the nail¿s holes can result from several factors, including (but not limited to) insufficient tightening of the nail holding screw, applying too much axial force on the construct or unsuitable bone geometry.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "during drilling for the proximal reconstruction screw, the distal drill was advanced through the device but struck the nail's screw hole, preventing normal passage." the surgery was completed using a free-hand technique.

• Brand Name: T2 ALPHA FEMUR ANTEGRADE - FEMORAL NAIL GT, RIGHT 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 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: 23767275
• Report Number: 0008031020-2025-02135
• Device Sequence Number: 21490645
• Product Code: HSB
• UDI-Device Identifier: 07613327285819
• UDI-Public: 07613327285819
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• 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): 03/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 23331038S
• Device Lot Number: UNKNOWN
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 03/06/2026
• 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
• Patient Sex: Unknown