BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T4, NON-RETAINING, MINI AO

    MDR report key: 14742790 · Received June 20, 2022

    Report

    Report Number
    1220246-2022-05098
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    May 27, 2022
    Report Date
    June 20, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867303553
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-29 T-4 DRIVER BROKE OFF IN THE TIP OF THE CORTICAL SCREW WHILE INSERTING IT INTO THE PLATE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: THIS WAS DISCOVERED DURING A PROXIMAL PHALANX FX PROCEDURE. NOTHING BROKE INSIDE THE CASE AND IT WAS COMPLETED SUCCESSFULLY WITH AN AR-18700-09 T-4 DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135682 DRIVER SHAFT, T4, NON-RETAINING, MINI AO ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. DRIVER SHAFT, T4, NON-RETAINING, MINI AO 1391940 00888867303553

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown