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 Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the stryker sales representative reported that during a case using the alpha femur antegrade, both recon screws missed the nail".Update on december 1 2025 "the case was completed using different screw holes 2x transvers and 1x gt screw.".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed during the investigation since the alleged failure was not reproduced during functional testing.The device inspection revealed the following: tissue protection sleeve, k-wire sleeve and targeting arm were received and shows normal signs of usage.It is evident from the external surface that the devices have been used previously.No significant damage or deformation seen with respect to the reported failure.A functional inspection was done on the returned targeting arm, drill, recon sleeve, k-wire sleeve using sample nail holding screw and nail.During testing, it was found that all the returned devices are functional, the reported misdrilling / mistargeting could not be reproduced since the drill/ k-wire is passing through the nail without causing any issue, therefore the event is not confirmed.Given the device was confirmed to be fully functional, the root cause of the reported event could not be determined.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: "the stryker sales representative reported that during a case using the alpha femur antegrade, both recon screws missed the nail".Update on (b)(6) 2025 "the case was completed using different screw holes 2x transvers and 1x gt screw.".

• 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: 23882510
• Report Number: 0008031020-2025-02290
• Device Sequence Number: 20010326
• Product Code: HSB
• UDI-Device Identifier: 07613327338652
• UDI-Public: 07613327338652
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K203819
• 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): 03/03/2026

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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