BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WRIST HOOK DORSAL IMPACTOR

    MDR report key: 7119454 · Received December 14, 2017

    Report

    Report Number
    2031009-2017-00031
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    October 27, 2017
    Report Date
    December 14, 2017
    Manufacturer
    TRIMED, INC
    Product Code
    LXH
    UDI-DI
    00842188113666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2017 A SALES REP REPORTED THAT TWO WRIST HOOK DORSAL IMPACTOR (IMPCT-WHD) WERE FOUND WITH RUST ON THE GRIP HANDLE. THE NONCONFORMING PARTS WERE FOUND UPON OPENING THE WRIST HOOK SET IN THE CLINICAL SETTING. THE IMPCT-WHD IS ENCLOSED IN THE WRIST HOOK SET, THE NONCONFORMING PART WAS VISIBLE UPON OPENING OF THE SET AND WAS NEVER REMOVED OUR TOUCHED, AND THE SET WAS IMMEDIATELY CLOSED BACK UP. THE ENTIRE SET WAS IMMEDIATELY REPLACED WITH AN ENTIRELY NEW SET OF PARTS AND TOOLS WERE USED, NO ADVERSE EVENTS WERE REPORTED. THIS IS THE FIRST TIME THAT THIS TYPE OF MALFUNCTION HAS OCCURRED FOR THIS PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899323 WRIST HOOK DORSAL IMPACTOR IMPACTOR LXH TRIMED, INC IMPCT-WHD 00842188113666

    Patients

    Seq Age Sex Outcome Treatment
    1