BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REAL INTELLIGENCE ROBOTIC DRILL

    MDR report key: 15092554 · Received July 25, 2022

    Report

    Report Number
    3010266064-2022-00536
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    July 3, 2022
    Report Date
    January 25, 2024
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757321
    PMA / PMN Number
    K201022
    Removal / Correction Number
    RES# 93620
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9 H3, H6: THE REAL INTELLIGENCE ROBOTIC DRILL, PART NUMBER ROB10013, SERIAL NUMBER SN500212, USED FOR TREATMENT, WAS RETURNED FOR EVALUATION. THE REPORTED PROBLEM COULD NOT BE CONFIRMED WITH A VISUAL INSPECTION. THE REPORTED PROBLEM WAS CONFIRMED WITH A FUNCTIONAL EVALUATION. A TEST CASE WAS BEGUN AND WHILE BURRING INTO A BLOCK OF PLASTIC, FOUR SYSTEM TIME OUT ERRORS OCCURRED. LOG FILES OF THE ERRORS WERE REVIEWED AND THE SYSTEM TIME OUTS WERE CAUSED BY BAD_EXPOSURE_POSITION_SENSOR ERRORS. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS ESTABLISHED. THE MOST LIKELY CAUSE OF THIS EVENT IS THE BAD_EXPOSURE_POSITION_SENSOR ERRORS DUE TO CONNECTION ISSUES WITH THE SYSTEM. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT BASED ON THE INFORMATION PROVIDED, THERE WERE NO CLINICAL FACTORS WHICH WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. PATIENT IMPACT BEYOND THE REPORTED RECURRENT ERROR (X3), SUBSEQUENT SYSTEM ABORT WITH USE OF A COMPETITOR BACKUP DEVICE TO COMPLETE THE PROCEDURE, AND SURGICAL DELAY WOULD NOT BE ANTICIPATED, AS THERE WAS NO PATIENT HARM ALLEGED DUE TO THE REPORTED EVENTS. NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. IN THE EVENT OF A SYSTEM FAILURE, REFER TO THE RECOVERY PROCEDURE GUIDELINES IN THE REAL INTELLIGENCE CORI FOR KNEE ARTHROPLASTY USER MANUAL. A FAILURE CAN CONSIST OF, BUT IS NOT LIMITED TO, A SYSTEM SOFTWARE CRASH, UNRECOVERABLE HARDWARE FAILURE, HANDPIECE FAILURE WITH NO BACKUP AVAILABLE, TRACKER FAILURE OR LOSS OF CONTACT WITH BONE THAT IS UNRECOVERABLE, ETC. 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. A HISTORICAL REVIEW CONCLUDED THAT NO PRIOR ESCALATION ACTIONS ARE APPLICABLE TO THE SCOPE OF THE REPORTED COMPLAINT. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE. THE RISK LEVEL IS STILL ADEQUATE. FURTHER INVESTIGATION INTO THE REPORTED FAILURE IS BEING CONDUCTED TO DETERMINE IF ADDITIONAL ESCALATION ACTIONS ARE REQUIRED. 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. H3, H6, H10

    Additional Manufacturer Narrative · 0

    H3, H6: THE REAL INTELLIGENCE ROBOTIC DRILL, PN: ROB10013, SN: (B)(6) USED FOR TREATMENT WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR EVALUATION, THEREFORE VISUAL AND FUNCTIONAL INSPECTIONS COULD NOT BE PERFORMED. THE SOFTWARE FILES WERE DOWNLOADED FROM THE DEVICE AND PROVIDED FOR INVESTIGATION HOWEVER THE CASE FILES WERE NOT FOR THE OCCURRENCE DATE OF THIS COMPLAINT. THE REPORTED ¿SYSTEM TIME OUT¿ ERROR MESSAGES COULD NOT BE CONFIRMED. THE MOST LIKELY CONTRIBUTING FACTOR FOR THE ¿SYSTEM TIME OUT¿ ERRORS DURING BONE REMOVAL COULD BE DUE TO A PHYSICAL HARDWARE ISSUE WITH THE DRILL, SUCH AS JAMMING OF THE MOTOR ROTOR, OR THE TORQUE APPLIED ON THE DRILL WAS TOO HIGH FOR A PROLONGED TIME. IT ALSO COULD BE A SOFTWARE RELATED ISSUE. IN THE EVENT OF A SYSTEM FAILURE, REFER TO THE RECOVERY PROCEDURE GUIDELINES IN THE REAL INTELLIGENCE CORI FOR KNEE ARTHROPLASTY USER MANUAL. A FAILURE CAN CONSIST OF, BUT IS NOT LIMITED TO, A SYSTEM SOFTWARE CRASH, UNRECOVERABLE HARDWARE FAILURE, HANDPIECE FAILURE WITH NO BACKUP AVAILABLE, TRACKER FAILURE OR LOSS OF CONTACT WITH BONE THAT IS UNRECOVERABLE, ETC. THE CLINICAL/MEDICAL EVALUATION CONCLUDED: ¿PER COMPLAINT DETAILS, THE DRILL DID NOT PERFORM AS INTENDED WITH A ¿SYSTEM TIMEOUT¿ ERROR OCCURRING X 3 DURING INITIAL BURRING OF THE DISTAL FEMUR. REPORTEDLY, THE CASE WAS ABORTED, AND THE PROCEDURE WAS FINISHED WITH COMPETITORS¿ TECHNOLOGY WITH A 0-30-MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS ALLEGED PER THE FIELD REPORT. BASED ON THE INFORMATION PROVIDED, THERE WERE NO CLINICAL FACTORS WHICH WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. PATIENT IMPACT BEYOND THE REPORTED RECURRENT ERROR (X3), SUBSEQUENT SYSTEM ABORT WITH USE OF A COMPETITOR BACKUP DEVICE TO COMPLETE THE PROCEDURE, AND SURGICAL DELAY WOULD NOT BE ANTICIPATED, AS THERE WAS NO PATIENT HARM ALLEGED DUE TO THE REPORTED EVENTS. NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME.¿ THIS SITUATION IS CAPTURED IN THE RISK ASSESSMENT RELEASED AT THE TIME OF THE COMPLAINT. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE. AS A RESULT OF THE RISK ASSESSMENT THE DOCUMENTED RISK FILE REQUIRES FURTHER INVESTIGATION AND POSSIBLE ADJUSTMENT BY THE SITE QUALITY TEAM. A REVIEW OF MANUFACTURING RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTS. A REVIEW OF PRIOR ESCALATION ACTIONS WAS PERFORMED AND FOUND NO ACTIONS THAT ARE APPLICABLE TO THE SCOPE OF THE REPORTED COMPLAINT. THIS ISSUE WILL BE CONTINUOUSLY MONITORED THROUGH COMPLAINT INVESTIGATION AND POST MARKET SURVEILLANCE. BASED ON THE INVESTIGATION, NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE REAL INTELLIGENCE ROBOTIC DRILL, PART NUMBER ROB10013, SERIAL NUMBER (B)(6), USED FOR TREATMENT, WAS RETURNED FOR EVALUATION. THE REPORTED PROBLEM COULD NOT BE CONFIRMED WITH A VISUAL INSPECTION. THE REPORTED PROBLEM WAS CONFIRMED WITH A FUNCTIONAL EVALUATION. A TEST CASE WAS BEGUN AND WHILE BURRING INTO A BLOCK OF PLASTIC, FOUR SYSTEM TIME OUT ERRORS OCCURRED. LOG FILES OF THE ERRORS WERE REVIEWED AND THE SYSTEM TIME OUTS WERE CAUSED BY BAD_EXPOSURE_POSITION_SENSOR ERRORS. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS ESTABLISHED. 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. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT BASED ON THE INFORMATION PROVIDED, THERE WERE NO CLINICAL FACTORS WHICH WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. PATIENT IMPACT BEYOND THE REPORTED RECURRENT ERROR (X3), SUBSEQUENT SYSTEM ABORT WITH USE OF A COMPETITOR BACKUP DEVICE TO COMPLETE THE PROCEDURE, AND SURGICAL DELAY WOULD NOT BE ANTICIPATED, AS THERE WAS NO PATIENT HARM ALLEGED DUE TO THE REPORTED EVENTS. NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. IN THE EVENT OF A SYSTEM FAILURE, REFER TO THE RECOVERY PROCEDURE GUIDELINES IN THE REAL INTELLIGENCE CORI FOR KNEE ARTHROPLASTY USER MANUAL. A FAILURE CAN CONSIST OF, BUT IS NOT LIMITED TO, A SYSTEM SOFTWARE CRASH, UNRECOVERABLE HARDWARE FAILURE, HANDPIECE FAILURE WITH NO BACKUP AVAILABLE, TRACKER FAILURE OR LOSS OF CONTACT WITH BONE THAT IS UNRECOVERABLE, ETC. 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. 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 FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE. THE 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, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, DURING INITIAL BURRING OF THE DISTAL FEMUR A "SYSTEM TIMEOUT" ERROR. THIS OCCURED THREE TIMES AND THE CASE WAS ABORTED. THE PROCEDURE WAS FINISHED WITH COMPETITORS TECHNOLOGY. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555043 REAL INTELLIGENCE ROBOTIC DRILL ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10013 00885556757321

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention REAL INTELLIGENCE CORI.