BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIO HANDPIECE

    MDR report key: 8824460 · Received July 24, 2019

    Report

    Report Number
    3010266064-2019-00104
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    June 27, 2019
    Report Date
    August 7, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556628515
    PMA / PMN Number
    K191223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: A1: UPDATED INFORMATION. H11: B5, G5: CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 0

    THE NAVIO HANDPIECE, INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR FURTHER EVALUATION AND A VISUAL INSPECTION WAS PERFORMED, WHICH CONFIRMED THE REPORTED EVENT. THE SNAP-LOCK NUT WAS BROKEN. THE ROOT CAUSE WAS FOUND TO BE A MECHANICAL COMPONENT FAILURE. AS PART OF CORRECTIVE ACTIONS, A NEW AND MORE ROBUST DESIGN OF THE SNAPLOCK HAS BEEN RELEASED A DEVICE HISTORY RECORD REVIEW FOUND NO CONDITIONS WHICH COULD CONTRIBUTE TO THE REPORTED EVENT AND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS DURING THE RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTS AND THIS ISSUE WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE NEW INFORMATION STATES THAT DELAY REPORTED WAS BEFORE THE SURGERY AND PATIENT WAS NOT UNDER ANESTHESIA, THEREFORE, IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLACK SNAP LOCK PIECE IS BROKEN AND ANOTHER TRAY WAS OPENED BEFORE SURGERY STARTED. ABOUT AN HOUR DELAY TO SURGERY START TIME. NO PATIENT INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK SNAP LOCK PIECE IS BROKEN AND ANOTHER TRAY WAS OPENED. DELAY GREATER THAN 30 MINUTES WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616694 NAVIO HANDPIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES PFSR110137 00885556628515

    Patients

    Seq Age Sex Outcome Treatment
    1