BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIO HANDPIECE

    MDR report key: 9984547 · Received April 22, 2020

    Report

    Report Number
    3010266064-2020-00320
    Event Type
    Malfunction
    Date Received
    April 22, 2020
    Date of Event
    October 25, 2016
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10, H3, H6: THE DEVICE, USED 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 THEY HAD DIFFICULTY INSERTING THE DRILL INTO THE HANDPIECE AND THE DRILL GUIDE SUPPORT WAS BENT. THE DHR COULD NOT BE REVIEWED AND IT WAS NOT CONFIRMED IF THE PRODUCT MET MANUFACTURING SPECIFICATIONS. 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, DURING A TKR SURGERY, WHILE SETTING UP THE EQUIPMENT IT WAS DIFFICULT TO INSERT THE DRILL INTO THE HANDPIECE: THE DRILL GUIDE SUPPORT WAS BENT. THE HANDPIECE COULD HOME AFTER DOING HANDPIECE CHARACTERIZATION TWICE AND PUSHING ON THE END OF THE DRILL WHEN IT STARTED TO MOVE FORWARD. IT WAS CHECKED THAT THE BUR WAS EVEN WITH THE LINE ON THE POINT PROBE BEFORE PROCEEDING. THE HANDPIECE WORKED AS EXPECTED FOR THE REMAINDER OF THE CASE. SURGERY STARTED LATE 15 MIN. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450980 NAVIO HANDPIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 101209 - ANSPACH EMAX 2 PLUS HAND PIECE - ROHS| 101209 - ANSPACH EMAX 2 PLUS HAND PIECE - ROHS