BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HIGH TORQUE DRILL

    MDR report key: 2082112 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01439
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 22, 2011
    Report Date
    April 1, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL WAS RECEIVED BY THE U.S MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. INTERNAL COMPONENTS WERE EVALUATED AND IT WAS DISCOVERED THAT THE ROTOR WAS NOT ROTATING FREELY DUE TO CORROSION BUILDUP. THE PRESENCE OF CORROSION CAN LEAD TO INCREASED FRICTION BETWEEN ROTATING COMPONENTS, RESULTING IN HEAT BEING GENERATED. THE ROTOR ASSEMBLY AND ASSOCIATED BEARINGS WERE REPLACED, AND ADDITIONAL PREVENTATIVE MAINTENANCE WAS ALSO PERFORMED. THE DEVICE WAS RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY THE DISTRIBUTOR, THE DRILL HEATED UP. THIS EVENT DID NOT OCCUR IN A SURGICAL ENVIRONMENT, SO THERE WAS NO PATIENT 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 UNIVERSAL HIGH TORQUE DRILL ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK