BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLCUT

    MDR report key: 2052504 · Received April 4, 2011

    Report

    Report Number
    2052504
    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 SHOULDER ARTHROSCOPY. HE WAS USING AN ARTHREX 4.0 MM BONE CUTTER 13CM CATALOG NUMBER AR-8400BC. HE COULD SEE ON THE MONITOR SCREEN THAT A PIECE OF METAL HAD BROKEN OFF THE TIP. ARTHREX REP WAS IN THE ROOM AND AWARE. SUCTION CANISTER DRAINED TO FIND METAL. SURGEON CANNOT BE SURE THAT ALL METAL WAS REMOVED FROM PATIENT. PATIENT DOES NOT APPEAR TO BE INJURED, BUT FUTURE ISSUES MAY ARISE IF METAL WAS NOT COMPLETELY REMOVED (I.E. MRI COMPATIBILITY ISSUES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOLCUT ARTHROSOPIC SHAVER HWE ARTHREX AR-8400BC 408200

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR