BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDPIECE, NAVIO (BBT HANDPIECE)

    MDR report key: 9984512 · Received April 22, 2020

    Report

    Report Number
    3010266064-2020-00237
    Event Type
    Injury
    Date Received
    April 22, 2020
    Date of Event
    September 18, 2015
    Report Date
    August 7, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K191223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10 H3, H6: THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. WE COULD NOT CONFIRM IF THERE WAS A RELATIONSHIP ESTABLISHED BETWEEN THE REPORTED EVENT AND THE DEVICE. DHR REVIEW FOUND THE DEVICE MET THE SPECIFICATIONS AT THE DATE WHEN IT WAS RELEASED TO THE DISTRIBUTION. A COMPLAINT HISTORY FOUND SIMILAR REPORTS, THIS ISSUE WILL CONTINUE TO BE MONITORED. THE SURGICAL SYSTEM USER'S MANUAL RELEASED AT THE TIME OF THE COMPLAINT PROVIDES COMPLETE AND DETAILED INSTRUCTIONS FOR DRILL ASSEMBLY. THIS IS AN IDENTIFIED FAILURE MODE WITHIN THE RISK ASSESSMENT. LOG FILES RELATED TO TRACKING/HANDPIECE MOTOR WERE REVIEWED AND NO NOTABLE ERRORS WERE FOUND. IN REFINE MODE, THE DRILL IS RETRACTED AND THE SYSTEM USES THE LOCATION OF THE GUARD TO "REFINE" AWAY BONE, THUS NO PROBLEMS DURING REFINE MODE. IN CUT MODE THE SYSTEM USES THE CALCULATED END OF THE BUR WHILE EXTENDED FROM THE GUARD AS THE LOCATION TO "REFINE/REMOVE" BONE. THEREFORE, IF THE DRILL IS NOT FULLY CONNECTED TO THE HANDPIECE THE SYSTEM WILL THINK THE BUR IS FULLY EXTENDED (VIRTUALLY) WHILE IT IS ACTUALLY STILL PARTIALLY GUARDED. THIS WOULD RESULT IN AN UNDERCUT IN THE CASE WHILE THE SYSTEM SHOWS FULL REMOVAL OF BONE VIRTUALLY. THE BUR CAN STILL REMOVE BONE SINCE IT WOULD STILL PROTRUDE SLIGHTLY FROM THE GUARD. THE ROOT CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE REFINING STAGE WHEN WE STARTED TO BUR, WITHOUT REMOVING BONE, THE BONE MODEL WOULD GO STRAIGHT TO THE WHITE TARGET SURFACE. ONCE AT THE WHITE TARGET SURFACE, THE BUR WOULD THEN REMOVE THE BONE. WHEN BURRING FEMUR POSTS, THE BONE MODEL SHOWED THAT HAD REACHED OUR TARGET SURFACE WHEN IN REALITY, IT WAS NOT EVEN CLOSE (WE THEN HAD TO SWITCH TO MANUAL TO BURR THE POSTS). OVERALL, THE SYSTEM WAS ACTING UP AND THE TECH MADE SURE THE DRILL WAS LOCKED IN PLACE. THE PHYSICIAN COULD HAVE BEEN MISTAKEN WHEN HE ASKED IF THE DRILL WAS LOCKED. NO PATIENT INJURIES REPORTED BEYOND THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450283 HANDPIECE, NAVIO (BBT HANDPIECE) ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention