BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIO BBT FOOTPEDAL

    MDR report key: 11814277 · Received May 12, 2021

    Report

    Report Number
    3010266064-2021-00369
    Event Type
    Injury
    Date Received
    May 12, 2021
    Date of Event
    April 26, 2021
    Report Date
    November 23, 2021
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556725597
    PMA / PMN Number
    K193120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE NAVIO SURGICAL SYSTEM (KOREA), PRODUCT ROB00079, (B)(6) USED FOR TREATMENT WAS NOT RETURNED FOR EVALUATION, HOWEVER A PHOTO WAS PROVIDED FOR REVIEW. THE PHOTO DURING THE CASE SHOWS THE "DRILL FOOTPEDAL CABLE IS NOT CONNECTED. RE-ESTABLISH CONNECTION AND PRESS 'DISMISS' TO CONTINUE." MESSAGE. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS CONFIRMED. A REVIEW OF MANUFACTURING AND SERVICE RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS CONCLUDED THIS WAS AN ISOLATED EVENT. THE MOST LIKELY CAUSE OF THIS EVENT IS AN INTERMITTENT CONNECTION FAILURE. THE NAVIO SURGICAL TECHNIQUE GUIDE FOR KNEE ARTHROPLASTY PROVIDES GUIDELINES FOR RECOVERING TO A FULLY MANUAL PROCEDURE IN THE ¿RECOVERY PROCEDURE GUIDELINES¿. THIS FAILURE IS AN IDENTIFIED FAILURE MODE WITHIN THE RISK ASSESSMENT. PER COMPLAINT DETAILS FROM KOREA, IT WAS REPORTED THAT, DURING FEMORAL BONE CUTTING IN A NAVIO-ASSISTED UKR SURGERY, A "DRILL FOOT PEDAL CABLE IS NOT CONNECTED" MESSAGE WAS DISPLAYED. AFTER RE-ESTABLISHING THE FOOT PEDAL CONNECTION, THE HANDPIECE CONTINUED TO FAIL WITH ABNORMAL TROUBLESHOOTING RESULTS. THE CASE WAS ABORTED AND THE PROCEDURE WAS COMPLETED WITH MANUAL INSTRUMENTATION WITH FEWER THAN A 30 MINUTE DELAY. PER CASE DETAILS, THE PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. NO ADDITIONAL REQUESTED CLINICALLY RELEVANT INFORMATION WAS PROVIDED. THE PATIENT IMPACT BEYOND THE REPORTED EVENTS, INCLUDING A LESS THAN 30 MINUTE DELAY COULD NOT BE DETERMINED. ADDITIONALLY, NO PATIENT HARM HAS BEEN ALLEGED. SHOULD ADDITIONAL CLINICALLY RELEVANT DOCUMENTATION BECOME AVAILABLE THE CLINICAL/MEDICAL TASK MAY BE RE-EVALUATED. ALTHOUGH NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME, ALL COMPLAINTS ARE MONITORED AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED OR PROVIDED AT A FUTURE DATE, THIS EVALUATION WILL BE REOPENED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING FEMORAL BONE CUTTING IN A NAVIO-ASSISTED UKR SURGERY, A "DRILL FOOTPEDAL CABLE IS NOT CONNECTED. RE-ESTABLISH CONNECTION AND PRESS 'DISMISS' TO CONTINUE." MESSAGE WAS DISPLAYED (CASE (B)(4)). AFTER RE-ESTABLISHING THE HANDPIECE AND THE FOOTPEDAL, THE HANDPIECE CONTINUE TO STOPPED WORKING AND ITS TEST RESULTS WERE ABNORMAL (MANY BLANK SEGMENTS) (CASE (B)(4)). THE CASE WAS ABORTED AND THE PROCEDURE WAS FINISHED WITH MANUAL INSTRUMENTATION WITHOUT ANY SIGNIFICANT DELAYS (FEWER THAN 30 MINUTES). NO PATIENT WAS HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710858 NAVIO BBT FOOTPEDAL ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES 00885556725597

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R| O