BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HIGH TORQUE DRILL

    MDR report key: 1942298 · Received December 22, 2010

    Report

    Report Number
    1811755-2010-02103
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 26, 2010
    Report Date
    November 29, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR SERVICE AND EVALUATION. THE INITIAL COMPLAINT COULD NOT BE VERIFIED. BASED ON THE INVESTIGATION DETAILS, THE DEVICE EXCEEDED THE MAXIMUM ALLOWABLE TEMPERATURE RISE DURING TESTING DUE TO LACK OF LUBRICATION IN THE BEARINGS. THE ROTOR, BEARINGS, ALONG WITH OTHER COMPONENTS, WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN TO SPARK AND SMOKE DURING TESTING OF THE EQUIPMENT. THE DEVICE WAS NOT BEING USED DURING A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES REPORTED.

    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