BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U2 DRILL

    MDR report key: 1923965 · Received December 9, 2010

    Report

    Report Number
    1811755-2010-01963
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL WAS RECEIVED BY THE MFR AND THE COMPLAINT WAS CONFIRMED. INTERNAL COMPONENTS WERE EVALUATED AND EXTENSIVE CORROSION WAS DISCOVERED WITHIN THE MOTOR AND ROTOR ASSEMBLIES. THE PRESENCE OF CORROSION CAN LEAD TO INCREASED FRICTION BETWEEN ROTATING COMPONENTS, RESULTING IN HEAT BEING GENERATED. THE ROTOR AND MOTOR ASSEMBLIES WERE REPLACED AND ADDITIONAL PREVENTATIVE MAINTENANCE WAS ALSO PERFORMED. THE DRILL WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE START OF A SURGICAL PROCEDURE, THE DRILL OPERATED WHEN THE TRIGGER WAS NOT ACTIVATED. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U2 DRILL DRILLS, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INC ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK