BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T10 HEXALOBE, CMP FT

    MDR report key: 10482015 · Received September 2, 2020

    Report

    Report Number
    1220246-2020-02106
    Event Type
    Injury
    Date Received
    September 2, 2020
    Date of Event
    August 17, 2020
    Report Date
    September 2, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867127166
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    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 THREE OF THE AR-8737-38 BROKE DURING USE FOR A METACARPAL FRACTURE REPAIR. THE FIRST DRIVE TIP BROKE OFF IF THE SCREW; IT WAS REMOVED. THEY TRIED THE NEXT TWO DRIVERS WHICH ALSO BROKE. THE ANCHOR WAS REMOVED FROM THE PATIENT AND A PLATE WAS USED TO COMPLETE THE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947615 T10 HEXALOBE, CMP FT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. T10 HEXALOBE, CMP FT UNKNOWN 00888867127166

    Patients

    Seq Age Sex Outcome Treatment
    1 Other