BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE CORI

    MDR report key: 11505221 · Received March 17, 2021

    Report

    Report Number
    3010266064-2021-00202
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 24, 2021
    Report Date
    January 11, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757420
    PMA / PMN Number
    K201022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE REAL INTELLIGENCE CORI, PN: ROB10024, SN: (B)(6) USED FOR TREATMENT WAS RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL EVALUATION WERE DONE ON THE CONSOLE AND NO VISUAL OR FUNCTIONAL NON-CONFORMANCES RELATED TO THE REPORTED EVENT IDENTIFIED. THE SOFTWARE FILES WERE DOWNLOADED FROM THE DEVICE AND PROVIDED FOR INVESTIGATION. SCREENSHOT REVIEW CONFIRMED THE ¿SYSTEM CONSOLE IS BAD¿ ERROR. THE LOG FILES WERE REVIEWED AND IT WAS DETERMINED THAT THE SOFTWARE FUNCTIONED AS INTENDED. A TCU HARDWARE ERROR (WITHIN THE CONSOLE) CAN CAUSE THE APPLICATION SOFTWARE TO THROW THE "SYSTEM CONSOLE IS BAD" ERROR, AND IS THE MOST LIKELY CAUSE OF THE REPORTED COMPLAINT. THE ¿SYSTEM CONSOLE IS BAD¿ ERROR MESSAGE IS A SYSTEM FAULT ERROR MESSAGE THAT REQUIRES THE USER TO RESTART OR SHUT DOWN THE CORI SYSTEM. REFER TO APPENDIX C IN OF THE REAL INTELLIGENCE CORI FOR KNEE ARTHROPLASTY USER MANUAL. IN THE EVENT OF A SYSTEM FAILURE, REFER TO THE RECOVERY PROCEDURE GUIDELINES IN THE REAL INTELLIGENCE CORI FOR KNEE ARTHROPLASTY USER MANUAL. A FAILURE CAN CONSIST OF, BUT IS NOT LIMITED TO, A SYSTEM SOFTWARE CRASH, UNRECOVERABLE HARDWARE FAILURE, HANDPIECE FAILURE WITH NO BACKUP AVAILABLE, TRACKER FAILURE OR LOSS OF CONTACT WITH BONE THAT IS UNRECOVERABLE, ETC. FURTHER REVIEW OF THE SCREENSHOTS SHOW THE USER HAVING ACCEPTED A HIP CENTER CALCULATION THAT WAS ABOVE THE RECOMMENDED THRESHOLD. THE NAVIO.LOG SHOWS MULTIPLE HIP CENTER CALCULATION ERRORS LEADING UP TO THE FINAL HIP CENTER CALCULATION. HIP CENTER ERRORS ARE TYPICALLY A RESULT OF HIP INSTABILITY. ALTHOUGH THE SCREENSHOTS CANNOT CONFIRM THE DIRECTION THE HIP CENTER POINTS WERE COLLECTED, THIS ISSUE CAN BE CREATED WHEN THE HIP IS MOVED IN THE SAME PLANE AS THE ENTIRE LEG INSTEAD OF THE HIP REMAINING IN A STATIONARY POSITION. THIS IS THE MOST LIKELY CAUSE CONSIDERING THE USER COULD NOT COLLECT THE HIP CENTER WITHOUT AN ERROR GREATER THAN 1.0. REFER TO THE USER¿S MANUAL WHEN COLLECTING HIP CENTER. MINIMIZE HIP MOVEMENT AND PIVOT THE FEMUR IN A SLOW, SMOOTH MOTION. ENSURE THE HIP DOES NOT MOVE SIGNIFICANTLY DURING ROTATION. A REVIEW OF MANUFACTURING RECORDS INDICATE THE SOFTWARE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTS, THIS ISSUE WILL CONTINUE TO BE MONITORED. THIS SITUATION IS CAPTURED IN THE RISK ASSESSMENT RELEASED AT THE TIME OF THE COMPLAINT. PRIOR ESCALATION CRITERIA WAS REVIEWED, AND THERE ARE NO PRIOR ESCALATION ACTIONS APPLICABLE TO THE SCOPE OF THE REPORTED COMPLIANT. ALTHOUGH NO FURTHER ACTION IS NECESSARY AT THIS TIME, THE ISSUE WILL BE CONTINUOUSLY MONITORED THROUGH COMPLAINT INVESTIGATION AND POST MARKET SURVEILLANCE.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE NUMBER: CASE-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORI TKA PROCEDURE, THE SURGEON NOTED THE HIP CENTER APPEARED TO BE BACKWARDS. UPON COMPLETION OF BONE PREP, THEY ALSO RECEIVED THE ERROR "SYSTEM CONSOLE IS BAD. PLEASE CONTACT ROBOTICS CUSTOMER SUPPORT". SO, THEY QUIT THE CASE, RE-ENTERED. THEY WERE ABLE TO PROCEED WITH A DELAY FEWER THAN 30 MINUTES. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399008 REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10024 00885556757420

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown