BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MAKAR INC

    MDR report key: 229336 · Received June 25, 1999

    Report

    Report Number
    1825883-1999-00002
    Event Type
    Malfunction
    Date Received
    June 25, 1999
    Date of Event
    May 10, 1999
    Report Date
    June 24, 1999
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Product Code
    HWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TAKE OUT SCREW DRIVER WAS BEING USED, WHILE TRYING TO REMOVE A METAL PERFIX SCREW IN PATIENT FEMUR. WHILE SCREWING THE TAKE OUT SCREW DRIVER INTO THE PERFIX SCREW, THE TIP OF THE TAKE OUT SCREW DRIVER BROKE OFF AND REMAINED LODGED IN THE PERFIX SCREW. THE PERFIX SCREW WAS LEFT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTRUMENT MAKAR INC TAKE OUT SCREW DRIVER HWB INSTRUMENT MAKAR, INC. 11061 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other