MAUDE Adverse Event Report: STRYKER GMBH T2 - TARGETING ARM TNS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18061001
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
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: "the t2 tibial nail was mounted on the nail adapter at the target bar and inserted into the tibia.With static locking (on both sides), it was not possible to reach the hole in the nail with the drill, resulting in a small difference that prevented the drill from drilling through the nail hole.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.Both devices were visually inspected and exhibit clear signs of wear and tear.Cracks are observed around the targeting arm at multiple junctions.Additionally, the nail handle shows deformation consistent with impact marks at the assembly section.Abrasive marks are also present on various surfaces, indicating repeated assembly and disassembly over extended periods of use.Functional inspection was conducted with a sample nail and drill with the received device, and we can observe misdrilling in the static lock setting, which is caused by wear and tear.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 the above investigation, the root cause can be attributed to wear and tear problem, as device is manufactured in 2014 and has been in use for over ten years.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the t2 tibial nail was mounted on the nail adapter at the target bar and inserted into the tibia.With static locking (on both sides), it was not possible to reach the hole in the nail with the drill, resulting in a small difference that prevented the drill from drilling through the nail hole.".

• Brand Name: T2 - TARGETING ARM TNS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 23220013
• Report Number: 0008031020-2025-01668
• Device Sequence Number: 8872797
• Product Code: LXH
• UDI-Device Identifier: 04546540196521
• UDI-Public: 04546540196521
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/19/2025

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: 18061001
• Device Lot Number: KHI143568
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2014
• 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