BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE CORI

    MDR report key: 10778641 · Received November 3, 2020

    Report

    Report Number
    3010266064-2020-01947
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    October 8, 2020
    Report Date
    October 6, 2021
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757420
    PMA / PMN Number
    K191223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE PRODUCT, RI CORI, ROB10024, (B)(6) INTENDED FOR USE IN TREATMENT WAS NOT RETURNED FOR EVALUATION; THUS, A VISUAL AND FUNCTIONAL EVALUATION COULD NOT BE PERFORMED, AND A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE COULD NOT BE DETERMINED. A REVIEW OF MANUFACTURING AND SERVICE RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. ALTHOUGH THE REPORTED PROBLEM WAS NOT CONFIRMED, A FACTOR THAT MAY HAVE CONTRIBUTED TO THE REPORTED SYMPTOM MAY BE ASSOCIATED WITH A SOFTWARE ISSUE. ALTHOUGH NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME, ALL COMPLAINTS ARE MONITORED AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED OR PROVIDED AT A FUTURE DATE, THIS EVALUATION WILL BE REOPENED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PARTIALLY BURRING THE TIBIA DURING A CORI TKA LAB/DEMO, THEY DECIDED TO SWAP A 6MM CYLINDRICAL BUR FOR A 6MM CYLINDRICAL BUR. THEY DIDN¿T ACTUALLY TAKE THE BUR OUT, BUT WERE JUST DEMONSTRATING THE WORKFLOW FOR TEACHING PURPOSES. UPON ADVANCING TO CALIBRATION, THE SCREEN WENT BLACK FOR ABOUT 10 SECONDS. WHEN IT CAME BACK ON THERE WAS AN ERROR MESSAGE. THE SYSTEM KICKED THEM OUT OF THE CASE. THEY RESUMED THE CASE AND WERE ABLE TO PICK UP WHERE THEY WERE LEFT OFF WITH A DELAY OF FEWER THAN 30 MINUTES. NO PATIENT WAS INVOLVED. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246541 REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10024 00885556757420

    Patients

    Seq Age Sex Outcome Treatment
    1