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	Perforation (2001)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "the t2 alpha gt targeter cause the lag screw reamer to miss the jig and nail.It cause the reamer to kick anterior and miss the nail.We had to re-drill and push the jig anterior to make the drill go posterior to get the lag screw drill through the sleeves and into the nail this failure in the jig caused the surgeon to create an extra hole in the patient femur as the reamer and screw missed completely anterior to nail".
Additional Manufacturer Narrative
The reported event could not be confirmed since the returned device was found to be functional and conforming to specifications.The device inspection revealed the following: the returned target device shows normal signs of usage with no apparent deformation or damage visible anywhere but just a few scratches & slight worn off surface.The device appeared to be in good condition.A pre-surgical functional test was performed with the returned target device and other sample instruments like sleeves, guide wire, drill & nail.Upon inspection, it was found that the functionality of the target device was given.The drill and guide wire could pass through all the possible targeting options without any issue; hence the alleged issue could not be confirmed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the exact cause of the alleged issue, why it occurred could not be confirmed or reproduced.The device was found functional, hence the issue is deemed to be user related.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the t2 alpha gt targeter cause the lag screw reamer to miss the jig and nail.It cause the reamer to kick anterior and miss the nail.We had to re-drill and push the jig anterior to make the drill go posterior to get the lag screw drill through the sleeves and into the nail this failure in the jig caused the surgeon to create an extra hole in the patient femur as the reamer and screw missed completely anterior to nail".

• 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: 22650341
• Report Number: 0008031020-2025-01311
• Device Sequence Number: 15669190
• Product Code: HSB
• UDI-Device Identifier: 07613327338652
• UDI-Public: (01)07613327338652(10)K18CCB6
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: KP493663
• 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): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 23533103
• Device Lot Number: KP493663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Sex: Male