BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE WOODPECKER

    MDR report key: 7731219 · Received July 27, 2018

    Report

    Report Number
    MW5078683
    Event Type
    Malfunction
    Date Received
    July 27, 2018
    Report Date
    July 26, 2018
    Manufacturer
    INTEGRATED MEDICAL TECHNOLOGIES USA, LLC
    Product Code
    GEY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WOODPECKER DEVICE CEASED FUNCTIONING WHILE BROACH WAS INSIDE FEMUR. HARDLE CANNOT BE REMOVED FROM BROACH WHILE IT'S INSIDE FEMUR. DISTRIBUTOR REP (B)(4) HAD TO OPEN ANOTHER WOODPECKER DEVICE TO ATTACH TO BROACH HARDLE. THIS RESULTED IN SURGERY INTRAOPERATIVE DELAY OF 20 MINS. THIS HAS HAPPENED BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568364 THE WOODPECKER MOTOR, SURGICAL INSTRUMENT GEY INTEGRATED MEDICAL TECHNOLOGIES USA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR