BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDPIECE, NAVIO (BBT HANDPIECE)

    MDR report key: 9994155 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00192
    Event Type
    Injury
    Date Received
    April 24, 2020
    Date of Event
    January 19, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10 H3, H6: THE DEVICE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. DHR REVIEW FOUND THE DEVICE MET THE SPECIFICATIONS AT THE DATE WHEN IT WAS RELEASED TO THE DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTS. 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. THE HANDPIECES ASSOCIATED WITH THIS REPORT WERE TESTED AND CHARACTERIZED. ALL FALL WITHIN ACCEPTABLE LIMITS OF THE HARDWARE. LOG FILES RELATED TO TRACKING/HANDPIECE MOTOR WERE REVIEWED AND NO NOTABLE ERRORS WERE FOUND. REASON BELIEVED TO HAVE CAUSED THIS DISCREPANCY BETWEEN GUI AND ACTUAL CUT SURFACE IS AN INCOMPLETE CONNECTION BETWEEN THE DRILL AND HANDPIECE. IF THE DRILL WAS NOT FULLY SEATED AND LOCKED INTO THE HANDPIECE THEN THE SYSTEM WOULD BE VIRTUALLY REMOVING BONE AT A FASTER RATE THAN THE ACTUAL REMOVAL OF BONE. THIS WOULD BE MOST EVIDENT IN THE SPEED CONTROL MODE WHERE THE HANDPIECE DRILL CARRIER IS STATIONARY. THE DISCREPANCY WAS NOT NOTICED UNTIL SPEED CONTROL MODE WAS UTILIZED THUS FURTHER BACKING UP THIS ANALYSIS. WE COULD NOT CONFIRM IF THERE WAS A RELATIONSHIP ESTABLISHED BETWEEN THE REPORTED EVENT AND THE DEVICE. THE ROOT CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, WHEN THE PHYSICIAN WAS DRILLING THE POST HOLES, HE MOVED TO DRILL THE SUPERIOR HOLE ON THE FEMUR AND IT SHOWED ON THE PLAN/SCREEN THAT IT HAD ALREADY BEEN DRILLED SHOWING ALL RED. HE WAS ABLE TO SEE CLEARLY THAT IT WAS NOT DEEP ENOUGH AND HAD TO GO FURTHER WITH NO CONTROL. THERE WERE ISSUES WITH HOMING AT THE BEGINNING OF THE CASE; HOWEVER, SEEMED TO RESOLVE IT AND MOVE FORWARD. PATIENT INJURIES WERE NOT REPORTED BEYOND THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459042 HANDPIECE, NAVIO (BBT HANDPIECE) ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1