BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT

    MDR report key: 9994110 · Received April 23, 2020

    Report

    Report Number
    3010266064-2020-00758
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    December 10, 2018
    Report Date
    August 4, 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: THE NAVIO HANDPIECE (PART NUMBER 110137 / SERIAL NUMBER (B)(6), INTENDED FOR USE IN TREATMENT, HAD A BROKEN SCREW ON (B)(6) 2018. THE BROKEN THUMBSCREW WAS INVESTIGATED UNDER 18-0761. UPON REVIEW, IT WAS ALSO FOUND TO HAVE A BROKEN SNAP LOCK NUT. A DEVICE HISTORY RECORD REVIEW FOUND NO CONDITIONS WHICH COULD CONTRIBUTE TO THE REPORTED EVENT AND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS DURING RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTS AND THIS ISSUE WILL CONTINUE TO BE MONITORED. THE NAVIO HANDPIECE WAS RETURNED FOR FURTHER EVALUATION AND THE INITIAL VISUAL/FUNCTIONAL INSPECTION WAS PERFORMED, WHICH CONFIRMED THE REPORTED EVENT. THE SNAP LOCK NUT WAS BROKEN. THE ROOT CAUSE OF THIS ISSUE WAS FOUND TO BE MECHANICAL COMPONENT FAILURE. AS PART OF CORRECTIVE ACTIONS, A NEW AND MORE ROBUST DESIGN OF THE SNAPLOCK HAS BEEN RELEASED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TECH STRIPED THE SCREW ON THE HANDPIECE; THE SCREW IS BROKEN IN THE HANDPIECE. THE DEVICE WAS NOT BEING USED WITH A PATIENT DURING THE EVENT. RESULTS OF THE INVESTIGATION HAVE CONCLUDED THAT THE SNAPLOCK ASSEMBLY WAS BROKEN, WHICH MAKES IT A REPORTABLE EVENT. THE INCIDENT WITH THE THUMBSCREW WAS BEEN ADDRESSED UNDER FIELD REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453100 HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1