BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER HIGH SPEED BUR ATTACHMENT

    MDR report key: 3083690 · Received April 29, 2013

    Report

    Report Number
    0001811755-2013-00956
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF OVERHEATING WAS CONFIRMED THROUGH FUNCTIONAL EVALUATION. UPON DISASSEMBLY, INTERNAL CORROSION AND DEBRIS WERE FOUND. THE PRESENCE OF CORROSION/DEBRIS IS LIKELY TO CAUSE OR CONTRIBUTE TO THE REPORTED EVENT DUE TO INCREASED FRICTION. THE ATTACHMENT IS NOT A REPAIRABLE DEVICE AND WILL THEREFORE NOT BE RETURNED TO THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORDLESS DRIVER HIGH SPEED BUR ATTACHMENT WAS OVERHEATING DURING PERFORMANCE TESTING. THE EVENT OCCURRED DURING A ROUTINE MAINTENANCE VISIT. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORDLESS DRIVER HIGH SPEED BUR ATTACHMENT WAS OVERHEATING DURING PERFORMANCE TESTING. THE EVENT OCCURRED DURING A ROUTINE MAINTENANCE VISIT. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183763 CORDLESS DRIVER HIGH SPEED BUR ATTACHMENT ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1