BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRILL

    MDR report key: 3232566 · Received July 18, 2013

    Report

    Report Number
    0001811755-2013-01667
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 25, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF THE DEVICE HAVING RUN ON WAS NOT CONFIRMED DURING FUNCTIONAL EVALUATION BY A MANUFACTURER TECHNICIAN. BASED ON A REVIEW OF THE RISK DOCUMENT, THE DEVICE CAN RUN WITHOUT ACTIVATION DUE TO MAGNETIC FIELD INTERFERENCE IN THE ENVIRONMENT OF THE DEVICE. A MAGNETIC FIELD CAN ACTIVATE THE DRILL'S HALL SENSOR IF IT IS TOO CLOSE TO THE DRILL, WHICH IS A POSSIBLE CAUSE OF THE REPORTED EVENT. DURING EVALUATION, CORROSION WAS FOUND THROUGHOUT SEVERAL INTERNAL COMPONENTS OF THE DEVICE. THE DEVICE WAS SERVICED AND RETURNED TO THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IN PROGRESS. FOLLOW UP WILL BE SUBMITTED ONCE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED AT THE USER FACILITY THE DEVICE RAN WITHOUT USER ACTIVATION AFTER THE TRIGGER WAS RELEASED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED AT THE USER FACILITY THE DEVICE RAN WITHOUT USER ACTIVATION AFTER THE TRIGGER WAS RELEASED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333619 UNIVERSAL DRILL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1