BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAST CUTTER

    MDR report key: 4221277 · Received November 3, 2014

    Report

    Report Number
    0001811755-2014-03917
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT, SAW IS GETTING REALLY HOT, WAS CONFIRMED. THE BEARINGS WERE NOISY AND WORN AND THE OUTPUT SHAFT ASSEMBLY AND HOOD ASSEMBLY WERE STRIPPED. THE ARMATURE WAS OBSERVED TO BE WORN AND THE BRUSHES WERE WORN. THE BEARINGS, HOOD, OUTPUT SHAFT ASSEMBLY, ARMATURE, AND BRUSHES WERE REPLACED ALONG WITH OTHER WORN COMPONENTS AND THE REPAIRED DEVICE WAS RETURNED TO THE CUSTOMER AFTER PASSING THE FINAL INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAST CUTTER WAS OVERHEATING DURING A CAST REMOVAL PROCEDURE AT USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701722 CAST CUTTER SAW, POWERED, AND ACCESSORIES HAB STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1