BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON ROHS ANSPACH CONSOLE - 200030

    MDR report key: 9984311 · Received April 21, 2020

    Report

    Report Number
    3010266064-2020-00608
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Date of Event
    December 17, 2018
    Report Date
    April 21, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    HBE
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE, USED FOR TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. THERE WAS NO SERIAL NUMBER, LOT NUMBER, OR PART NUMBER NOTED IN THE INITIAL INVESTIGATION DOCUMENTS SO WE ARE UNABLE TO CONDUCT A DHR REVIEW AS A PART OF THE INVESTIGATION. A COMPLAINT HISTORY REVIEW IDENTIFIED SIMILAR EVENTS. IT WAS REPORTED THAT SHUTTING DOWN AND REBOOTING THE NAVIO FIXED THE ISSUE. THIS IS INDICATIVE OF A FALSE ANSPACH E2 ERROR, WHEN THE E2 ERROR (WHICH TYPICALLY INDICATES A JAM) PRESENTS ITSELF WITHOUT A JAM AND CAN ONLY BE RESOLVED WITH A SYSTEM REBOOT. IN THESE CASES, THE E2 ERROR CANNOT BE CLEARED BY ALL OTHER TROUBLESHOOTING METHODS INCLUDING CHECKING THE DRILL COLLAR, REMOVING THE BUR FROM CONTACT WITH THE BONE AND SLOWLY DEPRESSING THE FOOT PEDAL, CHANGING DRILLS, AND VERIFYING AN UNLOCKED BUR BY SPINNING THE BUR BY HAND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN E2 ERROR OCCURED WHEN MOVED TO THE CUT SCREEN. IT WAS CHECKED THAT ANSPACH DRILL WAS IN CUT FEMUR AND NOT IN REFINE MODE. TRIED PRESSING ON PEDAL SLOWLY. SWITCHED OUT TO A NEW DRILL AND REPEATED THE STEPS, BUT THE DRILL DID NOT WORK. SO NAVIO WAS SHUT DOWN AND REBOOTED. THIS FIXED THE ISSUE. THERE WAS A SHORT SURGICAL DELAY REPORTED WITH NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443703 NON ROHS ANSPACH CONSOLE - 200030 DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 ANSPACH DRILL