BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLCUT

    MDR report key: 2052503 · Received April 4, 2011

    Report

    Report Number
    2052503
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ARTHREX
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS DOING A SHOULDER ARTHROSCOPY USING AN ARTHREX 5.5MM BURR, OVAL, CLEAR CUT 12 FLUTE. CATALOG NUMBER AR-8550COT. HE COULD SEE ON THE MONITOR SCREEN THAT A PIECE OF THE PLASTIC SHIELD WAS BROKEN OFF. ARTHREX REP WAS MADE AWARE AND CAME TO ROOM. SURGEON WAS ABLE TO REMOVE PLASTIC BROKEN PIECES, BUT SOME METAL MAY HAVE BEEN LEFT IN THE PATIENT. SURGEON CANNOT BE SURE IF HE REMOVED ALL THE METAL. PATIENT DOES NOT APPEAR TO HAVE ANY INJURIES, BUT THERE MAY BE LASTING EFFECTS (I.E. MRI COMPATIBILITY ISSUES) IN THE FUTURE FOR THIS PT IF ALL THE METAL WAS NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOLCUT SHAVER BLADE HWE ARTHREX AR-8550COT 384749

    Patients

    Seq Age Sex Outcome Treatment
    1 *