BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAST CUTTER, 8 FOOT CORD "

    MDR report key: 3000437 · Received March 12, 2013

    Report

    Report Number
    0001811755-2013-00507
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 27, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED. BARE WIRES THAT WERE NOTED TO BE CAUSING ARCING WERE FOUND ON THE ADAPTOR ASSEMBLY WHERE IT WAS ATTACHED TO A NON-STRYKER SWITCH. NON-STRYKER APPROVED WORK OR COMPONENTS CAN CAUSE AN ELECTRICAL ISSUE SUCH AS ARCING WHICH HAS THE POTENTIAL TO CAUSE THE UNIT TO SMOKE AND SPARK AS WELL AS BLOWING BREAKERS AS REPORTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED. THE DEVICE WAS RECEIVED FOR EVALUATION; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CAST CUTTER WAS SENT FOR EVALUATION DUE TO SMOKING WHEN THE DEVICE WAS PLUGGED IN. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    THE CAST CUTTER WAS SENT FOR EVALUATION DUE TO SMOKING WHEN THE DEVICE WAS PLUGGED IN. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103118 CAST CUTTER, 8 FOOT CORD " INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HAB STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1