MAUDE Adverse Event Report: STRYKER GMBH T2 ALPHA FEMUR ANTEGRADE - TARGETING ARM FEMUR GT; SCREW, FIXATION, BONE

Catalog Number	23533103
Medical Device Problem Codes	Material Discolored (1170); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the threads on the strike plate are damaged and doesn¿t grip into the nailing jigs properly.Upon inspection, a colour change was observed on the threads, indicating minor damage to this component.The damage appears to have resulted from the previously identified damaged strike plate threads.As a result, this component has also been scrapped.
Additional Manufacturer Narrative
Based on the available information, the device will not be returned; therefore, an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that "the threads on the strike plate are damaged and doesn¿t grip into the nailing jigs properly.Upon inspection, a colour change was observed on the threads, indicating minor damage to this component.The damage appears to have resulted from the previously identified damaged strike plate threads.As a result, this component has also been scrapped.
Additional Manufacturer Narrative
Correction to h6 removal of device code (material discolored).The reported event could not be confirmed because the device was not returned for evaluation and no additional evidence was provided.Based on the information available, it is possible that the observed damage may be associated with the previously identified strike plate thread deformation.However, in the absence of the returned device for verification, this relationship cannot be conclusively confirmed.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: T2 ALPHA FEMUR ANTEGRADE - TARGETING ARM FEMUR GT
• Common Device Name: SCREW, FIXATION, BONE
• 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: 24498278
• Report Number: 0008031020-2026-00358
• Device Sequence Number: 9960645
• Product Code: HWC
• UDI-Device Identifier: 07613327338652
• UDI-Public: (01)07613327338652(10)K0FEFA5
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: 23533103
• Device Lot Number: K0FEFA5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown