BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HIGH TORQUE DRILL

    MDR report key: 1851045 · Received September 28, 2010

    Report

    Report Number
    1811755-2010-01258
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MFR FOR SERVICE AND EVAL. THE INITIAL COMPLAINT COULD NOT BE VERIFIED. BASED ON THE INVESTIGATION DETAILS, THE BALL BEARINGS WERE CHIPPED AND THE MOTOR HAD EXCESSIVE VIBRATION AND NOISE. THE ROTOR ASSEMBLY AND BEARINGS WILL BE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING AT THE END OF A LUMBAR LAMINECTOMY. THERE WAS NO REPORTED PT OR USER INJURY, AND THE CASE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL HIGH TORQUE DRILL POWERED SIMPLE CRANIAL DRILLS, BURRS, TREPHINES, A HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK