BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXED DURAGUARD, 16MM

    MDR report key: 2243671 · Received July 28, 2011

    Report

    Report Number
    1811755-2011-02692
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RETURNED TO THE MFR FOR AN UNRELATED ISSUE AND UPON EVAL, AN OVERHEATING CONDITION WAS FOUND. THE OVERHEATING CONDITION WAS CAUSED BY LUBRICATION LOSS WITHIN THE BEARINGS, RESULTING IN EXCESSIVE FRICTION AND HEAT GENERATION. THE DRILL ATTACHMENT COULD NOT BE REPAIRED AND THEREFORE WAS NOT RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE U.S. 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 OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXED DURAGUARD, 16MM HBE STRYKER INSTRUMENTS KALAMAZOO 10356

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK