BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR U2 DRILL

    MDR report key: 1942365 · Received December 22, 2010

    Report

    Report Number
    1811755-2010-02095
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED BY THE MFR AND THE COMPLAINT WAS CONFIRMED. INTERNAL COMPONENTS WERE EVALUATED AND CORROSION WAS DISCOVERED IN THE MOTOR ASSEMBLY, ROTOR ASSEMBLY, AND BEARINGS. ALL CORRODED COMPONENTS WERE REPLACED AND THE DRILL WAS RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT THE DRILL OPERATED WHEN THE TRIGGER WAS NOT ACTIVATED. NO FURTHER INFO IS KNOWN. ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK