BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE ROBOTIC DRILL

    MDR report key: 18737921 · Received February 20, 2024

    Report

    Report Number
    3010266064-2024-00033
    Event Type
    Malfunction
    Date Received
    February 20, 2024
    Date of Event
    January 29, 2024
    Report Date
    April 1, 2024
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757321
    PMA / PMN Number
    K201022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: H3, H6: THE CORI, REAL INTELLIGENCE ROBOTIC DRILL, PART NUMBER ROB10013, (B)(6) , USED FOR TREATMENT WAS RETURNED FOR EVALUATION. IT IS NOTED THAT THE SPRINGS ON THE NOSEPIECE ARE TANGLED, AND THE STATIONARY COLLAR IS LOOSE AND IS SLIDING BACK AND FORTH. THE REPORTED PROBLEM WAS PARTIALLY VISUALLY CONFIRMED. A FUNCTIONAL EVALUATION WAS PERFORMED, AND THE REPORTED PROBLEM WAS CONFIRMED. A KPC TEST WAS COMPLETED, BUT IT WAS VERY HARD TO LOAD AND LOCK A BURR. AFTER THE KPC TEST, A VALIDATION OF THE BURR WAS COMPLETED. WHEN THE BURR WAS SET TO 0MM, IT WAS NOTED THAT IT SAT BEHIND THE DRILL GUARD BY 1MM. WHEN THE BURR WAS SET TO 1MM, IT WAS NOTED TO BE FLUSH WITH THE BURR GUARD. IT WAS ALSO NOTED THAT WHEN THE DRILL ATTACHMENT WAS LOCKED ON, THE DRILL¿S TRACKER HAD ABOUT 1-2MM OF WIGGLE ROOM, WHICH WAS CAUSED BY THE LOOSE STATIONARY COLLAR AND SPRINGS. THE MOST LIKELY CAUSE OF THIS EVENT WAS DUE TO PRODUCT MISHANDLING. A REVIEW OF MANUFACTURING RECORDS AND SERVICE RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS FOUND SIMILAR EVENTS. A HISTORICAL ESCALATION EVENT REVIEW WAS COMPLETED. A REVIEW OF PRIOR ESCALATION ACTIONS FOUND NO ACTIONS APPLICABLE TO THE SCOPE OF THE REPORTED COMPLAINT. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE DOCUMENTED RISK LEVEL IS STILL ADEQUATE. ALTHOUGH NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME, THE FAILURE MODE WILL CONTINUE TO BE CLOSELY MONITORED THROUGH COMPLAINT INVESTIGATION AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: THE CORI, REAL INTELLIGENCE ROBOTIC DRILL, PART NUMBER ROB10013, (B)(6), USED FOR TREATMENT WAS RETURNED FOR EVALUATION. IT IS NOTED THAT THE SPRINGS ON THE NOSEPIECE ARE TANGLED, AND THE STATIONARY COLLAR IS LOOSE AND IS SLIDING BACK AND FORTH. THE REPORTED PROBLEM WAS PARTIALLY VISUALLY CONFIRMED. A FUNCTIONAL EVALUATION WAS PERFORMED, AND THE REPORTED PROBLEM WAS CONFIRMED. A KPC TEST WAS COMPLETED, BUT IT WAS VERY HARD TO LOAD AND LOCK A BURR. AFTER THE KPC TEST, A VALIDATION OF THE BURR WAS COMPLETED. WHEN THE BURR WAS SET TO 0MM, IT WAS NOTED THAT IT SAT BEHIND THE DRILL GUARD BY 1MM. WHEN THE BURR WAS SET TO 1MM, IT WAS NOTED TO BE FLUSH WITH THE BURR GUARD. IT WAS ALSO NOTED THAT WHEN THE DRILL ATTACHMENT WAS LOCKED ON, THE DRILL¿S TRACKER HAD ABOUT 1-2MM OF WIGGLE ROOM, WHICH WAS CAUSED BY THE LOOSE STATIONARY COLLAR AND SPRINGS. THE MOST LIKELY CAUSE OF THIS EVENT WAS DUE TO PRODUCT MISHANDLING. A REVIEW OF MANUFACTURING RECORDS AND SERVICE RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS FOUND SIMILAR EVENTS. A HISTORICAL ESCALATION EVENT REVIEW WAS COMPLETED. A REVIEW OF PRIOR ESCALATION ACTIONS FOUND NO ACTIONS APPLICABLE TO THE SCOPE OF THE REPORTED COMPLAINT. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE DOCUMENTED RISK LEVEL IS STILL ADEQUATE. ALTHOUGH NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME, 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 DURING A CORI ASSISTED TKA SURGERY, THE SURGEON WAS STRUGGLING TO FINISH BURRING THE GREEN LAYER. CHECKPOINTS ENSURED THE ARRAYS HAD NOT MOVED. THE SURGEON SWAPPED TO SPEED MODE AND FINISHED OFF BURRING NECESSARY BONE. OVER RESECTION DID NOT OCCUR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. IN ADDITION, WHEN THE DRILL WAS INSPECTED AFTER THE CASE, IT WAS NOTICED THAT THE ARRAY WAS ABLE TO SHIFT FORWARD AND BACKWARDS INSTEAD OF BEING LOCKED IN PLACE FOR JUST ROTATION, WHICH SEEMED LIKE A POTENTIAL SPRING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398156 REAL INTELLIGENCE ROBOTIC DRILL ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES 00885556757321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown REAL INTELLIGENCE CORI, ROB10024, (B)(6)