BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T10 DRIVER, RETAINING

    MDR report key: 20332198 · Received September 30, 2024

    Report

    Report Number
    1220246-2024-07894
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 18, 2024
    Report Date
    June 11, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00848665039320
    PMA / PMN Number
    K202489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6 BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO OVERSTRESSING A DEVICE THAT IS DAMAGED NATURALLY AND INEVITABLY AS A RESULT OF NORMAL WEAR OR AGING FROM REPEATED USAGE/REPROCESSING.

    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 09/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF A 5042-100 T10 DRIVER WAS USED WITH A TORQUE LIMITING HANDLE, YET THE THREADS WERE BENT, SO THEY DID NOT PROPERLY GRIP THE SCREWS. NO PIECES BROKE INSIDE THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY USING A T10 DRIVER FROM THE 2.7 MINI FRAG SET WITHOUT ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2585113 T10 DRIVER, RETAINING BONE FIXATION PLATE HRS ARTHREX, INC. T10 DRIVER, RETAINING UNK 00848665039320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown