BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIO HANDPIECE

    MDR report key: 9993964 · Received April 23, 2020

    Report

    Report Number
    3010266064-2020-00719
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    September 25, 2018
    Report Date
    August 12, 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, INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR INVESTIGATION. 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. FUNCTIONAL INVESTIGATION CHECKED THE DRILL GUIDE BY INSERTING A LONG ATTACHMENT INTO IT BACKWARDS. IT WAS BENT. THE HANDPIECE CHARACTERIZATION WAS DONE WITH THE DRILL AND LONG ATTACHMENT INSERTED, AND RESULTED IN A T1 MAX TORQUE OF 32. THE HANDPIECE WAS STERILIZED AND COOLED AGAIN, AND HANDPIECE CHARACTERIZATION WAS DONE WITH A DRILL. THE T1 MAX TORQUE WAS 28, CONFIRMING THAT THIS WAS NOT AN ISSUE OF THE MOTOR SEIZING AFTER STERILIZATION. IT IS LIKELY THAT THE BENT DRILL GUIDE SUPPORT CONTRIBUTED TO THE HIGH TORQUE VALUES. SINCE THE REPORTED T1 MAX TORQUE VALUES DID NOT DECREASE WITH EACH CHARACTERIZATION, IT IS POSSIBLE THAT THE DRILL WAS INCORRECTLY INSERTED, HOWEVER, THIS CANNOT BE CONFIRMED. A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT COULD BE ESTABLISHED. THE MALFUNCTION IS LIKELY DUE TO MECHANICAL COMPONENT FAILURE FROM BENDING OF THE HANDPIECE DRILL GUIDE SUPPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN UKR SURGERY, THE DRILL WOULD NOT HOME. THE HANDPIECE AND DRILL WERE ASSEMBLED APPROPRIATELY, BUT THE GEARS SEEMED TO BE BOUND UP. THE HANDPIECE TEST WAS FOUR TIMES WITH THE FOLLOWING MAX TORQUE RESULTS: 90, 82, 96, 86. THE HANDPIECE WAS SWAPPED OUT AND THE CASE WAS RESUMED WITHOUT ANY DELAY. THE PATIENT WAS NOT HARMED. THE RESULTS OF INVESTIGATION INDICATE THAT THE DRILL GUIDE SUPPORT WAS BENT, WHICH IS A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452778 NAVIO HANDPIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1