BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXED DURAGUARD, 16MM

    MDR report key: 1935467 · Received December 13, 2010

    Report

    Report Number
    1811755-2010-02006
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 4, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RETURNED TO THE MFR FOR AN UNRELATED ISSUE AND UPON EVAL, AN OVERHEATING CONDITION WAS DISCOVERED. INTERNAL COMPONENTS WERE EVALUATED AND EXTENSIVE DEBRIS AND CORROSION WAS DISCOVERED WITHIN THE UPPER BEARINGS. THE PRESENCE OF DEBRIS/CORROSION CAN LEAD TO INCREASED FRICTION BETWEEN ROTATING COMPONENTS, RESULTING IN HEAT BEING GENERATED. IMPROPER OR INADEQUATE CLEANING/STERILIZATION TECHNIQUES COULD CONTRIBUTE TO THE BUILD-UP OF DEBRIS/CORROSION WITHIN THIS DEVICE. THE DRILL ATTACHMENT COULD NOT BE REPAIRED AND WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MFR, THE DRILL ATTACHMENT HEATED UP. THIS EVENT DID NOT OCCUR IN A SURGICAL ENVIRONMENT, SO THERE WAS NO PT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXED DURAGUARD, 16MM DRILLS, BURS, TREPHINES & ACCESSORIES (SIMPLE, POW HBE STRYKER INSTRUMENTS KALAMAZOO 10071

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK