BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIO SURGICAL SYSTEM US

    MDR report key: 9993871 · Received April 23, 2020

    Report

    Report Number
    3010266064-2020-00880
    Event Type
    Injury
    Date Received
    April 23, 2020
    Date of Event
    November 7, 2018
    Report Date
    August 27, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K191223
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10 H3, H6: THE DEVICE WAS USED IN TREATMENT AND CASE LOG FILES AND SCREENSHOTS WERE NOT RETURNED FOR EVALUATION. THUS, VISUAL INSPECTION COULD NOT BE PERFORMED. DHR REVIEW FOUND THAT THE SOFTWARE VERSION (RC-6001) HAS BEEN VALIDATED. A COMPLAINT HISTORY REVIEW FOUND 1 SIMILAR REPORTS, THIS ISSUE WILL CONTINUE TO BE MONITORED. THIS FAILURE MODE IS IDENTIFIED WITHIN THE RISK ASSESSMENT. THE SURGICAL TECHNIQUE GUIDE RELEASED AT THE TIME OF THE COMPLAINT PROVIDES INSTRUCTIONS FOR FEMUR KINEMATIC AXIS. THE NAVIO SOFTWARE REQUIREMENTS SPECIFICATION (800035), THE KINEMATIC AXIS CONSISTENCY CHECK REQUIREMENT IS THAT DURING THE PRE-OPERATIVE KINEMATICS STAGE, NAVIO INTRA-OP SHALL COMPARE THE KINEMATIC AXIS OF ROTATION WITH THE INITIAL LONG AXIS OF THE PATIENT'S LEG (HIP CENTER TO ANKLE CENTER). FOR UKR, THE KINEMATIC AXIS SHALL BE WITHIN 10 DEGREES OF NORMAL TO THE LONG AXIS. THEREFORE, IT IS POSSIBLE THAT THE PATIENT'S ANATOMY MADE IT MORE THAN 10 DEGREES, WHICH THEN CAUSED THE ERROR MULTIPLE TIMES. FOR EXAMPLE, IF THE JOINT WAS LOOSER THAN NORMAL, THERE COULD HAVE BEEN A LOT OF TWISTING WHILE COLLECTING THE POINTS, MAKING IT DIFFICULT FOR THE SYSTEM TO IDENTIFY THE AXIS. HOWEVER, SINCE NO LOG FILES OR CASE SCREENSHOTS WERE RETURNED. WE CANNOT CONFIRM THIS. THE ROOT CAUSE CANNOT BE DETERMINED AFTER INVESTIGATION. A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, DURING NEUTRAL COLLECTION ON A LATERAL UKA, SURGEON RECEIVED THE MESSAGE: "THE KINEMATIC AXIS WAS COLLECTED INCORRECTLY AND MAY BE INACCURATE". THIS ERROR MESSAGE OCCURRED TWICE AFTER RECOLLECTING ANKLE AND HIP CENTERS, WHICH LED THE SURGEON TO PROCEED ANYWAY. SURGEON USED A COMBINATION OF MANUAL AND NAVIO TECHNIQUE TO FINISH THE CASE. THERE WAS NO DELAY OR PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452936 NAVIO SURGICAL SYSTEM US ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention