BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35.0MM ACUTRAK PLUS FIXATION SCREW

    MDR report key: 1875224 · Received October 19, 2010

    Report

    Report Number
    3025141-2010-00034
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 8, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    PMA / PMN Number
    K944330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED AN ACUMED POLARUS SCREW INTO THE PATIENTS ELBOW AND THE SCREW STRIPPED BEFORE INSERTION WAS COMPLETE. ABOUT THREE THREADS OF THE SCREW REMAIN OUTSIDE OF THE BONE. THE SURGEON TRIED USING A COMPETITORS SCREW REMOVAL SET, BUT IT DID NOT FIT THE ACUMED POLARUS SCREW. THE SCREW REMAINS IMPLANTED IN THE PATIENT. THE SURGEON REQUESTED AN ACUMED REMOVAL INSTRUMENT TO REMOVE THE SCREW IN APPROXIMATELY SIX WEEKS TIME AFTER THE BONE HAS HEALED. THE SURGERY WAS COMPLETED USING TWO DIFFERENT SCREWS WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 35.0MM ACUTRAK PLUS FIXATION SCREW ACUTRAK PLUS FIXATION SCREW HWC ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR