BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIOCOIDAL RASP.

    MDR report key: 9744490 · Received February 21, 2020

    Report

    Report Number
    MW5093194
    Event Type
    Malfunction
    Date Received
    February 21, 2020
    Date of Event
    February 14, 2020
    Report Date
    February 19, 2020
    Manufacturer
    ORCHID UNIQUE
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING A REVISION TKA. TO REMOVE THE OLD IMPLANTS, PHYSICIAN WAS USING A METAL CUTTING HELICOIDAL RASP. (#5130-080-030). WHILE USING, FIVE OF THEM BROKE. ALL PIECES WERE RETRIEVED FROM THE KNEE AND AN X-RAY WAS TAKEN IN THE OPERATING ROOM TO CONFIRM PLACEMENT OF NEW IMPLANTS AND TO CONFIRM THERE WAS NO METAL FROM THE RASPS RETAINED IN THE KNEE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205540 HELIOCOIDAL RASP. DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE ORCHID UNIQUE 5130-080-030
    205541 HELIOCOIDAL RASP. DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE ORCHID UNIQUE 5130-080-030
    205542 HELIOCOIDAL RASP. DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE ORCHID UNIQUE 5130-080-030
    205543 HELIOCOIDAL RASP. DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE ORCHID UNIQUE 5130-080-030
    205544 HELIOCOIDAL RASP. DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE ORCHID UNIQUE 5130-080-030

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR