BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REAL INTELLIGENCE 5MM CYLINDRICAL BUR

    MDR report key: 16808185 · Received April 25, 2023

    Report

    Report Number
    3010266064-2023-00074
    Event Type
    Injury
    Date Received
    April 25, 2023
    Date of Event
    April 5, 2023
    Report Date
    October 4, 2023
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757505
    PMA / PMN Number
    K193120
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE REAL INTELLIGENCE 5 MM CYLINDRICAL BUR, PART # ROB10035, LOT # 51070801, QUANTITY OF (B)(4), INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR EVALUATION. INSPECTING THE SUSPECT BUR, IT WAS OBSERVED THAT THE TAPER ON THE INSERTION POINT OF THE BUR IS A TRIANGULAR SHAPE, RATHER THAN A RECTANGULAR SHAPE AS EXPECTED. THE OTHER 5 BURS WHICH WERE RETURNED UNOPENED DO NOT SHOW THE SAME FLAW. A FUNCTIONAL EVALUATION WAS PERFORMED. THE REPORTED PROBLEM WAS CONFIRMED. TESTING FOUND THAT THE INSERTION POINT FLAW ON THE SUSPECT BUR WOULD NOT ALLOW IT TO LOCK INTO THE COLLET, MAKING IT IMPOSSIBLE TO COMPLETE THE INITIAL CALIBRATION STEPS. THE MOST LIKELY CAUSE WAS FOUND TO BE A MANUFACTURING ERROR WHICH SEEMS TO HAVE ONLY AFFECTED ONE OF THE BURS. THE INSERTION TIP SEEMS TO HAVE BEEN IMPROPERLY MILLED DURING THE MANUFACTURING PROCESS. A REVIEW OF MANUFACTURING RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS CONCLUDED THIS WAS AN ISOLATED EVENT. A HISTORICAL ESCALATION EVENT REVIEW WAS COMPLETED. THE REVIEW DETERMINED THAT PRIOR ESCALATION ACTIONS ARE APPLICABLE TO THE SCOPE OF THIS COMPLAINT HOWEVER NO FURTHER ESCALATION ACTION IS REQUIRED. THE REAL INTELLIGENCE CORI FOR KNEE ARTHROPLASTY USER MANUAL (500230 REV D) PROVIDES GUIDELINES FOR RECOVERING TO A FULLY MANUAL PROCEDURE IN THE "RECOVERY PROCEDURE GUIDELINES, APPENDIX D". DRAWING PRINT 101968 REV A, INCLUDES DIMENSIONS AND INSPECTIONS REQUIRED FOR THE END CONNECTOR GEOMETRY. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE INCLUDING A DOCUMENTED RISK LEVEL. 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

    THE REAL INTELLIGENCE 5 MM CYLINDRICAL BUR, PART # ROB10035, LOT # 51070801, QUANTITY OF 6, INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR EVALUATION. INSPECTING THE SUSPECT BUR, IT WAS OBSERVED THAT THE TAPER ON THE INSERTION POINT OF THE BUR IS A TRIANGULAR SHAPE, RATHER THAN A RECTANGULAR SHAPE AS EXPECTED. THE OTHER 5 BURS WHICH WERE RETURNED UNOPENED DO NOT SHOW THE SAME FLAW. A FUNCTIONAL EVALUATION WAS PERFORMED. THE REPORTED PROBLEM WAS CONFIRMED. TESTING FOUND THAT THE INSERTION POINT FLAW ON THE SUSPECT BUR WOULD NOT ALLOW IT TO LOCK INTO THE COLLET, MAKING IT IMPOSSIBLE TO COMPLETE THE INITIAL CALIBRATION STEPS. THE MOST LIKELY CAUSE WAS FOUND TO BE A MANUFACTURING ERROR WHICH SEEMS TO HAVE ONLY AFFECTED ONE OF THE BURS. THE INSERTION TIP SEEMS TO HAVE BEEN IMPROPERLY MILLED DURING THE MANUFACTURING PROCESS. A REVIEW OF MANUFACTURING RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS CONCLUDED THIS WAS AN ISOLATED EVENT. 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 REAL INTELLIGENCE CORI FOR KNEE ARTHROPLASTY USER MANUAL (500230 REV D) PROVIDES GUIDELINES FOR RECOVERING TO A FULLY MANUAL PROCEDURE IN THE "RECOVERY PROCEDURE GUIDELINES, APPENDIX D". THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE INCLUDING A DOCUMENTED RISK LEVEL. 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 CASE (B)(4).

    Additional Manufacturer Narrative · 0

    THE REAL INTELLIGENCE 5 MM CYLINDRICAL BUR, PART # ROB10035, LOT # 51070801, QUANTITY OF 6, INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR EVALUATION. INSPECTING THE SUSPECT BUR, IT WAS OBSERVED THAT THE TAPER ON THE INSERTION POINT OF THE BUR IS A TRIANGULAR SHAPE, RATHER THAN A RECTANGULAR SHAPE AS EXPECTED. THE OTHER 5 BURS WHICH WERE RETURNED UNOPENED DO NOT SHOW THE SAME FLAW. A FUNCTIONAL EVALUATION WAS PERFORMED. THE REPORTED PROBLEM WAS CONFIRMED. TESTING FOUND THAT THE INSERTION POINT FLAW ON THE SUSPECT BUR WOULD NOT ALLOW IT TO LOCK INTO THE COLLET, MAKING IT IMPOSSIBLE TO COMPLETE THE INITIAL CALIBRATION STEPS. THE MOST LIKELY CAUSE WAS FOUND TO BE A MANUFACTURING ERROR WHICH SEEMS TO HAVE ONLY AFFECTED ONE OF THE BURS. THE INSERTION TIP SEEMS TO HAVE BEEN IMPROPERLY MILLED DURING THE MANUFACTURING PROCESS. A REVIEW OF MANUFACTURING RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS CONCLUDED THIS WAS AN ISOLATED EVENT. A HISTORICAL ESCALATION EVENT REVIEW WAS COMPLETED. THE REVIEW DETERMINED THAT PRIOR ESCALATION ACTIONS ARE APPLICABLE TO THE SCOPE OF THIS COMPLAINT AND FURTHER INVESTIGATION INTO THE REPORTED FAILURE IS BEING CONDUCTED TO DETERMINE IF ADDITIONAL ESCALATION ACTIONS ARE REQUIRED. THE REAL INTELLIGENCE CORI FOR KNEE ARTHROPLASTY USER MANUAL (500230 REV D) PROVIDES GUIDELINES FOR RECOVERING TO A FULLY MANUAL PROCEDURE IN THE "RECOVERY PROCEDURE GUIDELINES, APPENDIX D". THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE INCLUDING A DOCUMENTED RISK LEVEL. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, WHILE SETTING-UP FOR A CORI-ASSISTED TKA, UPON DRILL CALIBRATION, THE FOLLOWING MESSAGE KEPT APPEARING: "CALIBRATION VERIFICATION ERROR: FAILED TO VERIFY THE ROBOTIC DRILL CALIBRATION". A COMBINATION OF THREE DIFFERENT DRILLS, POINT PROBES, DRILL ATTACHMENTS AND LONG ATTACHMENTS WERE TRIED FROM ALL THREE CORI INSTRUMENT SETS, AS WELL AS DELETING AND ENTERING NEW CASE. IN ADDITION, THE CORI CONSOLE WAS SHUT DOWN AND TURNED BACK ON. HOWEVER, THE ERROR PERSISTED. SURGERY WAS PERFORMED, WITHOUT DELAY, BY MANUAL PROCEDURE INSTEAD. AFTER THE PROCEDURE WAS COMPLETED, CALIBRATION WAS SUCCESSFUL BY USING A DIFFERENT BURR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187121 REAL INTELLIGENCE 5MM CYLINDRICAL BUR ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10035 51070601 00885556757505

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention REAL INTELLIGENCE CORI(PN:ROB10024,SN:(B)(6).