BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, NAVIO (BBT HANDPIECE)

    MDR report key: 9996815 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00200
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    April 30, 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

    H3, H6: THE DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT WHILE SETTING UP FOR A DEMO, THERE WAS HOMING DIFFICULTY AND DIFFICULTY INSERTING THE ANSPACH DRILL INTO THE HANDPIECE. 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: THERE WAS DEBRIS INSIDE OF THE DRILL GUIDE SUPPORT. THIS WOULD MAKE IT DIFFICULT FOR THE USER TO INSERT THE ANSPACH DRILL AND ATTACHMENT INTO THE HANDPIECE. ALSO WHILE INSIDE THE HANDPIECE, THERE WOULD BE A LOT OF FRICTION DUE TO THE EXCESS DEBRIS, CAUSING THE HANDPIECE TO REACH THE MAXIMUM HOMING TORQUE (40%) WITHOUT REACHING THE END WALL OF THE PROBE. ADDITIONALLY, THERE APPEARED TO BE A BEND IN THE DISTAL END OF THIS SAME COMPONENT. BOTH OF THESE ISSUES CAN CAUSE HOMING PROBLEMS BY BLOCKING/IMPEDING THE MOVEMENT OF THE DRILL THROUGH THE HANDPIECE. 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 THE DEMO CASE, IT WAS DIFFICULT TO LOCK THE HANDPIECE INTO THE DRILL. THE DRILL WAS RE-ASSEMBLED BUT STILL HAVING ISSUES. THE DRILL WAS ABLE TO LOCK INTO THE HANDPIECE AND WAS ABLE TO GET THROUGH THE CALIBRATION SCREEN IN THE WORKFLOW (AFTER 7-10 THRESHOLD ERRORS) AND WHEN THE HANDPIECE WENT HOME, IT SEEMED AS THOUGH THE DRILL WAS STUCK AND WOULDN'T MOVE FORWARD TO HOME. THE DRILL AND THE HANDPIECE WERE SWAPPED OUT. THE DEVICE WAS NOT BEING USED WITH A PATIENT DURING THE EVENT. 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
    461713 HANDPIECE, NAVIO (BBT HANDPIECE) ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 101209 (ANSPACH DRILL)| 101209 (ANSPACH DRILL)