BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIO HANDPIECE

    MDR report key: 9994185 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00426
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    February 14, 2017
    Report Date
    August 3, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K191223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: H3, H6: THE DEVICE, INTENDED FOR USE IN TREATMENT, WAS NOT MADE AVAILABLE TO THE DESIGNATED COMPLAINT UNIT FOR EVALUATION. THUS, VISUAL AND FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. IT WAS REPORTED THAT THE DRILL GUIDE SUPPORTS ON TWO HANDPIECES WERE BENT. THE OTHER HANDPIECE WAS INVESTIGATED UNDER 17-0045-1. 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. A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT COULD NOT BE ESTABLISHED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUES ARE MECHANICAL COMPONENT FAILURE FROM BENDING OF THE HANDPIECE DRILL GUIDE SUPPORT OR IF DEBRIS WAS STUCK IN THE DRILL GUIDE SUPPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DRILL GUIDE SUPPORT ON THE HANDPIECE WAS BENT. AS THIS WAS NOTICED DURING SET-UP, THE PATIENT WAS NOT INVOLVED AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459685 NAVIO HANDPIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention