BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T10 DRIVER, RETAINING

    MDR report key: 23341242 · Received October 20, 2025

    Report

    Report Number
    1220246-2025-04700
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    October 9, 2025
    Report Date
    February 19, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00848665039320
    PMA / PMN Number
    K202489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PICTURES, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL FIELD DATA, ARTHREX CONCLUDED THE MOST LIKELY CAUSE OF THE REPORTED FAILURE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, SPECIFICALLY EXCESSIVE FORCE. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED; THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO EVIDENCE OF THE FAILURE WAS RECEIVED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 10/09/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT A 5042-100 T10 DRIVER TWISTED AT THE END AND STRIPPED. NO ISSUES WERE REPORTED DURING THE PROCEDURE, AND THE PATIENT WAS NOT AFFECTED. THIS WAS IDENTIFIED AFTER THE PROCEDURE, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801159 T10 DRIVER, RETAINING BONE FIXATION PLATE HRS ARTHREX, INC. T10 DRIVER, RETAINING 230141 00848665039320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown