BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUTRAK 2

    MDR report key: 2042355 · Received March 31, 2011

    Report

    Report Number
    2042355
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 31, 2011
    Manufacturer
    ACCUMED
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    SEVERAL (2) SMALL PIECES OF THE TIP OF THE SCREWDRIVER BROKE OFF WHILE SCREWING A SCREW INTO THE SURGICAL SITE. SCREWDRIVER WAS ORIGINAL ITEM FROM SET PURCHASED SEVERAL YEARS AGO. OPERATIVE SITE WAS RIGHT GREAT TOE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUTRAK 2 SCREWDRIVER HXX ACCUMED HT-1120 W26130

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR