BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, NAVIO (BBT HANDPIECE)

    MDR report key: 9996827 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00204
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    June 5, 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. IT WAS REPORTED THAT WHILE PREPARING FOR A CASE, THEY WERE ATTEMPTING TO PUT THE ASSEMBLED DRILL WITH LONG ATTACHMENT AND BUR INTO THE HANDPIECE AND IT WAS DIFFICULT TO PUT IN. THE CUSTOMER WAS ABLE TO GET THE DRILL FULLY SEATED INTO THE HANDPIECE. THE CUSTOMER EXPERIENCED A HOMING ERROR THAT THE DRILL WAS JAMMED. 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: VISUAL INSPECTION OF THE HANDPIECE SHOWS SMALL SCRATCHES ON ONE SIDE OF THE DISTAL END OF THE HANDPIECE. FUNCTIONAL INVESTIGATION REVEALED THAT THESE SCRATCHES ARE PART OF A SLIGHT BEND IN THE DRILL GUIDE SUPPORT, CAUSING SOME BURS ON THE INTERIOR AND BLOCKING THE LONG ATTACHMENT FROM SLIDING THROUGH SMOOTHLY. THIS IS WHAT CAUSED THE HOMING ERROR(S). THE EXTRA TORQUE IT REQUIRES TO FORCE THE LONG ATTACHMENT THROUGH THE DRILL GUIDE SUPPORT CAUSES THE MOTOR TO EXCEED THE HOMING TORQUE AND PRESENT A JAMMING ERROR/HOMING FAILURE. 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 AT THE BEGINNING OF THE CASE, IT WAS DIFFICULT TO PUT THE DRILL AND LONG ATTACHMENT INTO THE HANDPIECE. WHEN THE HANDPIECE WAS CALIBRATED, A HOMING ERROR WAS DISPLAYED. AT THIS POINT, THE HANDPIECE WAS REPLACED, COMPLETING THE CASE CORRECTLY. 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
    461928 HANDPIECE, NAVIO (BBT HANDPIECE) ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1