MAUDE Adverse Event Report: STRYKER GMBH T2 ALPHA FEMUR ANTEGRADE - TARGETING ARM FEMUR GT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23533103
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: ¿the thread of the strike plate no longer engages with the thread of the antegrade.Both threads appear to be defective.¿.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: ¿the thread of the strike plate no longer engages with the thread of the antegrade.Both threads appear to be defective.¿.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: strike plate and target device were received and threads of both the devices were found damaged.External threads of the strike plate which engages with target device are found severely deformed, initial threads are completely flattened and further consecutive threads are bent, followed by some threads in good shape.Similarly, the initial threads of the target device also show deformation and damage, due to impact load.These observations clearly indicate that the alignment between strike plate and target device was improper, only a few threads of strike plate were engaged with target device and due to excessive impact load most probably in the form of hammering, threads got damaged, due to which these devices cannot be assembled for further usage.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.Based on investigation, the root cause was attributed to a user related issue.The event was caused by application of excessive impact load when the target device and strike plate were not properly engaged with each other.If more information is provided, the case will be reassessed.

• Brand Name: T2 ALPHA FEMUR ANTEGRADE - TARGETING ARM FEMUR GT
• 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: 24054633
• Report Number: 0008031020-2026-00036
• Device Sequence Number: 18478831
• Product Code: HSB
• UDI-Device Identifier: 07613327338652
• UDI-Public: (01)07613327338652(10)K0D38FD
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• 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: KP472990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• 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