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	06/18/2025
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: "t2 tibial aiming device has play in the fixation to the metal post.Aiming with sleeve at holes in the nail impaired." how was the issue solved? free-hand-technique with careful usage.
Event or Problem Description
As reported: "t2 tibial aiming device has play in the fixation to the metal post.Aiming with sleeve at holes in the nail impaired." how was the issue solved? free-hand-technique with carful usage.
Additional Manufacturer Narrative
Correction: please refer to section d4 lot#.The reported event could not be confirmed since the device was returned for evaluation and found to be functional, as no play was observed in the testing.The returned targeting arm was received and visually inspected, revealing slight scratches and usage marks on the device.A functional inspection was conducted with the returned targeting arm, sample nail sleeve, and drill, during which the device was found to be functional.The drill could easily be moved to the desired hole without contacting the nail surface.Also, while inserting the insert into the carbon fiber, no play was observed.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 user related, as in the functional inspection device was found to be functional.If any additional information is provided, the investigation will be reassessed.

• 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: 22496748
• Report Number: 0008031020-2025-01079
• Device Sequence Number: 7029288
• Product Code: LXH
• UDI-Device Identifier: 04546540196521
• UDI-Public: (01)04546540196521(11)200320(10)K04F79B
• 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): 10/13/2025

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: KHI011281
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2020
• 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