BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRA LONG ANGLED SABER ATTACHMENT

    MDR report key: 2130043 · Received May 5, 2011

    Report

    Report Number
    1811755-2011-01533
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RETURNED TO THE MANUFACTURER FOR AN UNRELATED ISSUE AND UPON EVALUATION, AN OVERHEATING CONDITION WAS DISCOVERED. INTERNAL COMPONENTS WERE EVALUATED, WHICH REVEALED THAT THE BEARINGS WERE SEIZED AND CONTAMINATED WITH AN UNK SUBSTANCE. IF BEARINGS ARE UNABLE TO ROTATE FREELY, EXCESSIVE FRICTION MAY RESULT AMONG ROTATING COMPONENTS, CAUSING 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 MANUFACTURER, 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 EXTRA LONG ANGLED SABER ATTACHMENT ERL STRYKER INSTRUMENTS KALAMAZOO 09138

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK