BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXED DURAGUARD, 25MM

    MDR report key: 2130036 · Received May 5, 2011

    Report

    Report Number
    1811755-2011-01604
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS REC'D BY THE MFR, AND THE COMPLAINT WAS CONFIRMED. BASED ON THE QUALITY INVESTIGATION, DEBRIS WAS DISCOVERED WITHIN THE UPPER BEARINGS, OF THE DRILL ATTACHMENT. THE PRESENCE OF DEBRIS CAN LEAD TO INCREASED FRICTION BETWEEN ROTATING COMPONENTS, RESULTING IN HEAT BEING GENERATED. IMPROPER OR INADEQUATE CLEANING/STERILIZATION TECHNIQUES CAN CONTRIBUTE TO THE BUILDUP OF FOREIGN MATERIAL WITHIN THIS DEVICE. THE DEVICE COULD NOT BE REPAIRED ONCE EVALUATED AND WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE START OF A PROCEDURE THE DRILL ATTACHMENT HEATED UP. THERE WAS NO REPORT OF ANY ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP DRILL ATTACHMENT. THERE WAS NO MEDICAL INTERVENTION REQUIRED, NO DELAY IN PROCEDURE, AND NO ADVERSE CONSEQUENCES ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXED DURAGUARD, 25MM HBE STRYKER INSTRUMENTS KALAMAZOO 10198

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK