BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIO HANDPIECE

    MDR report key: 9993976 · Received April 23, 2020

    Report

    Report Number
    3010266064-2020-00728
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    August 23, 2018
    Report Date
    August 10, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K191223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE NAVIO HANDPIECE INTENDED FOR USE IN TREATMENT, HAD A BROKEN SNAP LOCK NUT AND A LOOSE BLACK RUBBER HARD STOP PRIOR TO A PROCEDURE ON 23-AUG-2018. THERE WAS NO IMPACT ON THE CASE. THE DEVICE WAS NOT BEING USED ON A PATIENT DURING THE REPORTED EVENT AND NO INJURIES WERE REPORTED. 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. THE NAVIO HANDPIECE WAS RETURNED FOR FURTHER EVALUATION. SERVICE RECORD (SR# 210614) IS NOT AVAILABLE AND THE PART WAS SCRAPPED. A VISUAL AND FUNCTIONAL INVESTIGATION COULD NOT BE PERFORMED. THE ROOT CAUSE OF THIS ISSUE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE SEEMS UNABLE TO MOVE THE DRILL IN AND OUT AS IT SHOULD. THE PROBLEM HAS BEEN TRACED TO THE BLACK RUBBER PART, WHICH HAS GOTTEN LOOSE AND IS INTERFERING WITH THE CALIBRATION. SOME OF THE RUBBER MAY HAVE ALSO BEEN CAUGHT INTO THE MOVING MECHANISMS. THE SNAP LOCK NUT HAS BROKEN LOOSE. AS NOTICED DURING IN-SERVICE, NO CASE WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452798 NAVIO HANDPIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1