MAUDE Adverse Event Report: STRYKER GMBH T2 - NAIL HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18061002
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "before surgery the staff wanted to try out the nail.The connected it with targeting device and it was not possible to disconnect them.Different system was used for surgery".
Additional Manufacturer Narrative
The reported event could not be confirmed since the affected device was not returned, and no other evidence was shared for evaluation.A device inspection was not possible since the affected device was not returned.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More information as well as the affected device must be available in order to determine the exact root cause of the issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: T2 - NAIL HANDLE
• 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: 24284026
• Report Number: 0008031020-2026-00114
• Device Sequence Number: 21313980
• Product Code: LXH
• UDI-Device Identifier: 04546540196538
• UDI-Public: 04546540196538
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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
• Report Date (Section B): 02/06/2026

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: 18061002
• Device Lot Number: KHI012274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2020
• 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