BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE CORI

    MDR report key: 14928690 · Received July 6, 2022

    Report

    Report Number
    3010266064-2022-00516
    Event Type
    Malfunction
    Date Received
    July 6, 2022
    Date of Event
    June 14, 2022
    Report Date
    January 24, 2024
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757420
    PMA / PMN Number
    K193120
    Removal / Correction Number
    RES# 93620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL 30 DAY MDR.

    Additional Manufacturer Narrative · 0

    H3, H6: THE REAL INTELLIGENCE CORI, PART NUMBER ROB10024, (B)(6), USED FOR TREATMENT WAS NOT RETURNED FOR EVALUATION, THEREFORE, A VISUAL AND FUNCTIONAL EVALUATION COULD NOT BE COMPLETED. A REVIEW OF THE LOGFILES AND SCREENSHOTS WERE COMPLETED, AND IT WAS CONFIRMED THAT THE USER WAS RECEIVING MULTIPLE SYSTEM TIME OUT ERRORS. IT WAS FOUND THAT ON LINE 979, 985, 1026, 1032, 1038, 1071, 1077, 1083, ETC. OF THE NAVIO LOGS, THERE WERE BAD EXPOSURE POSITION SENSOR ERRORS PRESENTED. THE MOST LIKELY CAUSE OF THIS EVENT WAS A BAD EXPOSURE POSITION SENSOR. CORI-V1.4.3 HAS BEEN VALIDATED ON PP-181 REV D. A REVIEW OF MANUFACTURING RECORDS INDICATES THE SOFTWARE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS FOUND SIMILAR EVENTS. THE SCOPE OF THIS CASE, PART NUMBER, LOT, OR SERIAL NUMBER IS ASSOCIATED WITH CAPA-226, NC-3182, PRA-2020-79-PL AND NO FURTHER ESCALATION ACTION IS REQUIRED. THE ISSUE WILL BE CONTINUOUSLY MONITORED THROUGH COMPLAINT INVESTIGATION AND POST MARKET SURVEILLANCE. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE DOCUMENTED RISK LEVEL IS STILL ADEQUATE. FURTHER INVESTIGATION INTO THE REPORTED FAILURE IS BEING CONDUCTED TO DETERMINE IF ADDITIONAL ACTIONS ARE REQUIRED. THE FAILURE MODE WILL CONTINUE TO BE CLOSELY MONITORED THROUGH COMPLAINT INVESTIGATION AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    H3, H6: THE REAL INTELLIGENCE CORI, PART NUMBER ROB10024, (B)(6), USED FOR TREATMENT WAS NOT RETURNED FOR EVALUATION, THEREFORE, A VISUAL AND FUNCTIONAL EVALUATION COULD NOT BE COMPLETED. A REVIEW OF THE LOGFILES AND SCREENSHOTS WERE COMPLETED, AND IT WAS CONFIRMED THAT THE USER WAS RECEIVING MULTIPLE SYSTEM TIME OUT ERRORS. IT WAS FOUND THAT ON LINE 979, 985, 1026, 1032, 1038, 1071, 1077, 1083, ETC. OF THE NAVIO LOGS, THERE WERE BAD EXPOSURE POSITION SENSOR ERRORS PRESENTED. THE MOST LIKELY CAUSE OF THIS EVENT IS ASSOCIATED WITH A FAILURE OF THE DRILL EXPOSURE MOTOR DUE TO THE THERMO-MECHANICAL STRESS INDUCED WITHIN THE MOTOR AT THE ENCODER AND ELECTRICAL NOISE ON THE CONSOLE ERROR STATUS INPUTS TO THE DRILL EXPOSURE MOTOR ENCODER. CORI-V1.4.3 HAS BEEN VALIDATED ON PP-181 REV D. A REVIEW OF MANUFACTURING RECORDS INDICATES THE SOFTWARE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS FOUND SIMILAR EVENTS. WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. A HISTORICAL REVIEW CONCLUDED THAT THE LOT, SERIAL NUMBER OR PART NUMBER REPORTED IN THIS EVENT IS RELATED TO A CORRECTIVE/PREVENTIVE ACTION ALREADY IMPLEMENTED. THE ISSUE WILL BE CONTINUOUSLY MONITORED THROUGH COMPLAINT INVESTIGATION AND POST MARKET SURVEILLANCE. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE DOCUMENTED RISK LEVEL IS STILL ADEQUATE. CONTINUOUS IMPROVEMENTS HAVE BEEN MADE TO THE CORI ROBOTIC DRILL AND MANUFACTURING PROCESSES TO REDUCE DRILL DISCONNECTION ERROR MESSAGES. THESE IMPROVEMENTS CONSISTED OF: 1. A HARDWARE UPDATE TO THE CORI CONSOLE TO REDUCE NOISE ON THE INTERNAL ELECTRONICS. 2. AN UPDATE TO THE CORI SYSTEM¿S SOFTWARE AND FIRMWARE TO IMPROVE THE USER EXPERIENCE WHEN ERROR MESSAGES ARE DISPLAYED. 3. A HARDWARE UPDATE TO THE CORI DRILL TO REDUCE MECHANICAL STRESS ON DRILL EXPOSURE THE MOTOR. THE FIRST TWO IMPROVEMENTS ARE FULLY DEPLOYED. THE THIRD IMPROVEMENT IS BEING DEPLOYED FOR NEW ORDERS AND AS DRILLS ARE RETURNED FOR ROUTINE SERVICING. ALSO, SMITH+NEPHEW IS VOLUNTARILY PERFORMING A RECALL/FIELD NOTIFICATION FOR THE CORI REAL INTELLIGENCE ROBOTIC DRILL. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED THE COMPLAINT WILL BE REOPENED. THE FAILURE MODE WILL CONTINUE TO BE CLOSELY MONITORED THROUGH COMPLAINT INVESTIGATION AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, WHEN BEGINNING TO MILL THE SECOND TIBIA TWIN PEG HOLE IN A CORI ASSISTED TKA SURGERY, A SYSTEM TIME OUT ERROR OCCURRED. THEY HIT CONTINUE AND THE REAL INTELLIGENCE ROBOTIC DRILL REINITIALIZED. AS SOON AS THE SURGEON TOUCHED THE BONE WITH THE BURR, THEY RECEIVED THE ERROR AGAIN. THEY CHECKED THAT THE BURR WAS LOCKED IN, TRIED TO BURR AGAIN AND RECEIVED THE TIME OUT AGAIN. THEY ENSURE THAT THE LONG ATTACHMENT WAS ON AND THEY HIT CONTINUE AGAIN AND RECEIVED THE TIME OUT ERROR. AFTER THEY HIT CONTINUE, THEY WENT TO THE CHANGE BURR SCREEN TO SWITCH THE LONG ATTACHMENT. WHEN THEY TRIED TO UNLOCK THE BURR THEY RECEIVED THE SYSTEM TIMEOUT FOLLOWED BY AN INTERNAL ERROR. AS THERE WAS NO BACKUP AVAILABLE, THE PROCEDURE WAS COMPLETED WITH MANUAL INSTRUMENTATION WITH A 10 MINUTES DELAY. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421672 REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10024 00885556757420

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown RI ROB DRILL (ROB10013, (B)(6))