BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL

    MDR report key: 2896559 · Received November 20, 2012

    Report

    Report Number
    1811755-2012-04143
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORROSION WAS DISCOVERED THROUGHOUT THE INTERNAL COMPONENTS OF THE DEVICE, INCLUDING THE MOTOR, WHICH IS A PROBABLE CAUSE OF THE DEVICE CONTINUING TO RUN WHEN THE TRIGGER WAS RELEASED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY A MFR FIELD SERVICE TECH AT THE USER FACILITY, THE DEVICE DID NOT STOP RUNNING WHEN THE TRIGGER WAS RELEASED. NO PT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO DRILL ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK