MAUDE Adverse Event Report: STRYKER GMBH TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE; 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	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "on a t2 alpha femoral nail (antegrade) : the jig lined up when checked outside of the patient, but when the handle was rotated to get a more central guide wire position in the head on the lateral view - the wire was missing the nail and going anterior to it.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the targeting arm was returned, without the k-wire and nail involved in the event.The device is in good condition overall.There is no damage, deformation or any noticeable wear marks.The received targeting arm was tested with compatible and fully functional nail and k-wire.The k-wire was inserted through the dedicated k-wire hole on the targeting arm and was reached the junction of the nail and insertion post as intended.The wire was not missing the nail and going anterior to it as reported.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 improper use during surgery, as the device was returned and tested to be conforming to specifications and fully functional.It is also worth noting the k-wire involved in the event was not returned and would have been necessary to perform a full-picture investigation of the event.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "on a t2 alpha femoral nail (antegrade): the jig lined up when checked outside of the patient, but when the handle was rotated to get a more central guide wire position in the head on the lateral view - the wire was missing the nail and going anterior to it.".

• Brand Name: TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21739993
• Report Number: 0008031020-2025-00592
• Device Sequence Number: 8626202
• Product Code: HSB
• UDI-Device Identifier: 07613327338652
• UDI-Public: (01)07613327338652(11)220216(10)K07F1E4
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/10/2025

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: KP469548
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2022
• 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