BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HIGH TORQUE DRILL

    MDR report key: 2090236 · Received April 19, 2011

    Report

    Report Number
    1811755-2011-01308
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL WAS RECEIVED BY THE U.S. MFR AND THE COMPLAINT WAS CONFIRMED. INTERNAL COMPONENTS WERE EVALUATED AND CORROSION WAS DISCOVERED WITHIN THE ROTOR ASSEMBLY. THE PRESENCE OF CORROSION CAN LEAD TO INCREASED FRICTION BETWEEN ROTATING COMPONENTS, RESULTING IN HEAT BEING GENERATED. ADDITIONALLY, A CUT WAS DISCOVERED IN THE POWER CORD, WHICH IS A COMPONENT OF THE MOTOR ASSEMBLY. A DAMAGED MOTOR ASSEMBLY CAN ALSO RESULT IN HEAT BEING GENERATED, WHEN THE DRILL IS OPERATED. THE MOTOR ASSEMBLY AND ROTOR ASSEMBLY WERE REPLACED, AND ADD'L PREVENTATIVE MAINTENANCE WAS ALSO PERFORMED. THE DRILL WAS RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A MFR TECHNICAL SPECIALIST, THAT THE DRILL HEATED UP. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, 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 UNIVERSAL HIGH TORQUE DRILL ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK