BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE ROBOTIC DRILL

    MDR report key: 24299645 · Received February 9, 2026

    Report

    Report Number
    3010266064-2026-00033
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 12, 2026
    Report Date
    March 16, 2026
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757321
    PMA / PMN Number
    K201022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: 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. NOTHING WAS VISUALLY IDENTIFIED THAT LEADS TO THE REPORTED SCENARIO. THE REPORTED PROBLEM WAS CONFIRMED WITH A FUNCTIONAL EVALUATION. A TEST CASE WAS PERFORMED. DURING THE SETUP A RETRACTION TIME VERIFICATION ERROR OCCURRED, WHICH COULD NOT BE CLICKED AWAY. A KPC TEST WAS PERFORMED. RANDOM EXPOSURE AND MAXIMUM RETRACTION TIME FAILED. THE MAXIMUM RETRACTION TIME HAD A VALUE OF 47. THE DRILL WAS OPENED FOR FURTHER INVESTIGATION. THE EXPOSURE MOTOR WAS TESTED AND PASSED. THE MOTORS WERE REMOVED AND THE DRILL WAS INSPECTED FURTHER. IT WAS NOTICED THAT THE CARRIAGE AND O-RING 101778 HAD AN EXCESSIVE AMOUNT OF GREASE. THE CARRIAGE WAS INSPECTED. NO DEFECTS WERE FOUND. THE CARRIAGE AND O-RING WERE CLEANED AND A KPC TEST WAS PERFORMED. ALL TEST PASSED. THE MAXIMUM RETRACTION TIME HAD A NORMAL VALUE OF 38. A TEST CASE WAS PERFORMED WHICH COULD BE COMPLETED WITHOUT ANY FAILURES OCCURRING. A COMPLAINT HISTORY REVIEW WAS PERFORMED BY PART NUMBER, AND SIMILAR COMPLAINTS WERE IDENTIFIED. A REVIEW BY SERIAL NUMBER WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE IDENTIFIED. A REVIEW OF MANUFACTURING RECORDS INDICATES THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. 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 NO PRIOR ESCALATION ACTIONS ARE APPLICABLE TO THE SCOPE OF THE REPORTED COMPLAINT. WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE MOST LIKELY CAUSE OF THE INCREASED RETRACTION TIME MAY HAVE BEEN CAUSED BY EXCESS VACUUM GREASE ON THE CARRIAGE CREATING FRICTION, WEAR OVER TIME, OR A COMBINATION OF MULTIPLE FACTORS. BASED ON THE INVESTIGATION, NO CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME. 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 Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, AT THE POINT OF STARTING BONE REMOVAL A REAL INTELLIGENCE ROBOTIC DRILL ERROR MESSAGE APPEARED ON SCREEN. DURING DIAGNOSTIC RETRACTION TIME DID NOT PASS THE TEST. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, CHANGING TO A MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354333 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).