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

Catalog Number	18063211
Medical Device Problem Codes	Mechanical Jam (2983); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "after the surgery, the instruments was difficult to be disassembled as connection part of the nail adapter was worn.".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "after the surgery, the instruments was difficult to be disassembled as connection part of the nail adapter was worn.".
Additional Manufacturer Narrative
The reported event could be confirmed since the threads of returned device is worn out as alleged and could result in assembling / disassembling impairment of the device.The device inspection revealed the following: nail adapter was received and threads of the connected part were found worn out.The coating has also come off due to excess contact with the mating part, most probably due to application of excess torsional force while assembling mating parts and axial load during usage (nail insertion).A functional inspection was done on the returned nail adapter using a sample nut and it was observed that the sample nut could be assembled onto the nail adapter despite the threads of the nail adapter being worn out.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 application of excess torsional force and axial load during usage.If more information is provided, the case will be reassessed.

• Brand Name: T2 - NAIL ADAPTER
• 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: 23882689
• Report Number: 0008031020-2025-02291
• Device Sequence Number: 9464337
• Product Code: LXH
• UDI-Device Identifier: 04546540708489
• UDI-Public: 04546540708489
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: 18063211
• Device Lot Number: K0D672B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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
• Patient Age: 50 YR
• Patient Sex: Female