BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, NAVIO (BBT HANDPIECE)

    MDR report key: 9996841 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00202
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    May 6, 2015
    Report Date
    April 24, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K191223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10 H3, H6: THE DEVICE, USED IN TREATMENT, WAS RETURNED FOR INVESTIGATION. THE CUSTOMER REPORTED THAT THERE WAS DIFFICULTY INSERTING THE DRILL/LONG ATTACHMENT INTO THE NAVIO HANDPIECE. ONCE THEY WERE ABLE TO INSERT THE DRILL/LONG ATTACHMENT, THERE WAS A HOMING FAILURE. DHR REVIEW FOUND THAT NO CONDITIONS THAT COULD CONTRIBUTE TO THE REPORTED EVENT WERE FOUND. THE REPORTED PRODUCT MET MANUFACTURING SPECIFICATIONS PRIOR TO BEING RELEASED FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTS. THE INITIAL VISUAL/FUNCTIONAL INVESTIGATION FOUND THAT: THE DRILL GUIDE SUPPORT WAS DAMAGED AND NO LONGER PERFECTLY CIRCULAR. THERE WERE NUMEROUS HANDPIECE HOMING FAILURES (OVER 10) AND EACH ONE FAILED DUE TO TRAVELLING LESS THAN THE EXPECTED DISTANCE. THIS CONFIRMED THAT THE CONTRIBUTING FACTOR WAS THE BENT DISTAL TIP OF THE HANDPIECE. THIS PROBLEM WAS REPLICATED 5 TIMES IN HOUSE DURING FUNCTIONAL TESTING. A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT COULD BE ESTABLISHED. THE MALFUNCTION IS LIKELY DUE TO MECHANICAL COMPONENT FAILURE FROM BENDING OF THE HANDPIECE DRILL GUIDE SUPPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET UP, WAS DIFFICULT TO INSERT THE DRILL INTO THE HANDPIECE. IT WAS ALMOST LIKE THE DRILL WAS SLIGHTLY TOO BIG FOR THE HANDPIECE. WHEN TRIED TO HOME, THE DRILL DIDN'T EVEN SEEM TO MOVE IN THE HANDPIECE AND HOMING FAILED. A NEW DRILL AND LONG ATTACHMENT WERE USED, BUT THIS ALSO FAILED. FINALLY, THE HANDPIECE WAS SWITCHED OUT AND WAS ABLE TO HOME SUCCESSFULLY. NO SURGICAL DELAY OR PATIENT INJURY WAS REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE DRILL GUIDE SUPPORT ON THE HANDPIECE WAS BENT, WHICH MAKES IT A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462146 HANDPIECE, NAVIO (BBT HANDPIECE) ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR