BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON ROHS ANSPACH CONSOLE - 200030

    MDR report key: 9996838 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00590
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    January 29, 2018
    Report Date
    April 24, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    HBE
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: 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. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. 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 DURING PROCEDURE AN ERROR OCCURRED ON THE ANSPACH CONSOLE. DOCTOR WAS INSTRUCTED TO SLOWLY PRESS DOWN ON THE FOOT PEDAL OFF THE BONE SURFACE. THEN THE ANSPACH DRILL WAS SWITCHED AND FINALLY RE-BOOTED TO CLEAR THE ERROR. THERE WAS A SHORT DELAY WITH NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462143 NON ROHS ANSPACH CONSOLE - 200030 DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1