BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIO HANDPIECE

    MDR report key: 9989219 · Received April 23, 2020

    Report

    Report Number
    3010266064-2020-00328
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    December 6, 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

    H3, H6: THE DEVICE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. IT WAS REPORTED THAT THE HANDPIECE / DRILL FAILED HOMING SEVERAL TIMES DURING A CASE. THE INITIAL VISUAL/FUNCTIONAL INVESTIGATION FOUND THAT: THE VISUAL INSPECTION REVEALED A BENT DRILL GUIDE SUPPORT. 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. THE PROBABLE CAUSE OF THE ISSUE WAS A MECHANICAL COMPONENT FAILURE. A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT COULD BE ESTABLISHED. VISUAL AND FUNCTIONAL INSPECTION OF THE HANDPIECE CONFIRMED THAT THE DRILL GUIDE SUPPORT ON THE HANDPIECE WAS BENT, WHICH WAS CAUSING THE REPORTED HOMING DIFFICULTIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN UNSPECIFIED SURGERY, THE HANDPIECE / DRILL FAILED HOMING SEVERAL TIMES. UNSNAPPING THE PROBE AND SNAPPING IT BACK ON WAS TRIED, BUT THE DRILL ITSELF WAS NOT MOVING WHEN TRYING TO HOME. IT WAS CHECKED THAT THE DRILL WAS PROPERLY LOCKED INTO THE HANDPIECE, AND IT WAS. THE CASE WAS EXITED AND A HANDPIECE TEST WAS PERFORMED TWICE: BOTH TIMES THE TORQUE WAS 84. WHEN WENT BACK INTO THE CASE, THE DRILL WOULD NOT RETRACT ALL THE WAY. HOMING WAS TRIED ONCE MORE, BUT THE DRILL STILL DID NOT MOVE. A NEW HANDPIECE / DRILL HOMED AS EXPECTED. SURGERY WAS DELAYED A FEW MINUTES. THE PATIENT WAS NOT INVOLVED AT THE TIME, AS THIS HAPPENED WHEN THE EQUIPMENT WAS SET-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454764 NAVIO HANDPIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

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