BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE ROBOTIC DRILL

    MDR report key: 10784577 · Received November 4, 2020

    Report

    Report Number
    3010266064-2020-01959
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 15, 2020
    Report Date
    December 15, 2023
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757321
    PMA / PMN Number
    K191223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE CORI DRILL P/N ROB10013 (B)(6) USED IN TREATMENT WAS RETURNED. NOTHING WAS IDENTIFIED VISUALLY THAT CONTRIBUTED TO THE REPORTED PROBLEM. A REVIEW OF LOG FILES CONFIRM THAT A "ROBOTICS DRILL DISCONNECT ERROR" WAS THROWN. A FUNCTIONAL EVALUATION WAS PERFORMED. A FUNCTIONAL EVALUATION WAS PERFORMED. A KPC TEST WAS ATTEMPTED AND FAILED. THE REPORTED PROBLEM WAS CONFIRMED. THE DRILL THROWS A "ROBOTIC DRILL DISCONNECT ERROR" WHEN PLUGGED IN. THE USAGE IS ABOVE THE RECOMMENDED USES AND THE DRILL NEEDS SERVICED. IT SEEMS AS THOUGH THE EXPOSURE MOTOR IS BROKEN. THE COLLET WILL NOT MOVE OUT TO ACCEPT A BUR, THE DRILL ATTACHMENT GETS LOCKED ON THE DRILL AND WILL NOT COME OFF. A REVIEW OF DEVICE RECORDS USING THE NC DATABASE(S), (LEGACY BBT, CAWEB4 AND SMARTSOLVE) CONFIRMED NO ABNORMALITIES WERE REPORTED ON THIS DEVICE DURING MANUFACTURE. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. THE MOST LIKELY CAUSE OF THIS EVENT WAS MECHANICAL FAILURE OF THE EXPOSURE MOTOR. BASED ON THE INVESTIGATION, NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    H3, H6: THE CORI DRILL P/N ROB10013 SN (B)(6) USED IN TREATMENT WAS RETURNED. NOTHING WAS IDENTIFIED VISUALLY THAT CONTRIBUTED TO THE REPORTED PROBLEM. A REVIEW OF LOG FILES CONFIRM THAT A "ROBOTICS DRILL DISCONNECT ERROR" WAS THROWN. A FUNCTIONAL EVALUATION WAS PERFORMED. A FUNCTIONAL EVALUATION WAS PERFORMED. A KPC TEST WAS ATTEMPTED AND FAILED. THE REPORTED PROBLEM WAS CONFIRMED. THE DRILL THROWS A "ROBOTIC DRILL DISCONNECT ERROR" WHEN PLUGGED IN. THE USAGE IS ABOVE THE RECOMMENDED USES AND THE DRILL NEEDS SERVICED. IT SEEMS AS THOUGH THE EXPOSURE MOTOR IS BROKEN. THE COLLET WILL NOT MOVE OUT TO ACCEPT A BUR, THE DRILL ATTACHMENT GETS LOCKED ON THE DRILL AND WILL NOT COME OFF. A REVIEW OF DEVICE RECORDS USING THE NC DATABASE(S), (LEGACY BBT, CAWEB4 AND SMARTSOLVE) CONFIRMED NO ABNORMALITIES WERE REPORTED ON THIS DEVICE DURING MANUFACTURE. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE DOCUMENTED RISK LEVEL IS STILL ADEQUATE. 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 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. 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, AND 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. ADDITIONAL INFORMATION: H7 CORRECTED DATA: H6 (MEDICAL DEVICE PROBLEM CODE).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A CORI TKA CADAVER LAB, THE DRILL FAILED WITH A "BAD_EXPOSURE_POSITION_SENSOR" ERROR. IT MIGHT BE THAT THERE WAS A LEAK INTO THE DRILL. THE OVERHEAT MAY HAVE BEEN A SHORTING OF CONNECTIONS, OR PERHAPS THE VIOLENT ACTIONS MADE ITS INTERNALS HEAT UP CONSIDERABLY. NO PATIENT WAS INVOLVED. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252006 REAL INTELLIGENCE ROBOTIC DRILL ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10013 00885556757321

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown