BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T15 HEXALOBE, ISO, CANN.

    MDR report key: 11655645 · Received April 13, 2021

    Report

    Report Number
    1220246-2021-02894
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 13, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867263765
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A QUANTITY TWO AR-8750-03 DRIVERS BROKE OFF AS THE SURGEON WAS TIGHTENING THE SCREW. THE SURGEON HAD TO MAKE A LARGER INCISIONS TO REMOVE THE BROKEN FRAGMENTS OUT OF THE HEAL OF THE FOOT. ALL FRAGMENTS WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557987 T15 HEXALOBE, ISO, CANN. ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. T15 HEXALOBE, ISO, CANN. UNK 00888867263765

    Patients

    Seq Age Sex Outcome Treatment
    1