BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE ROBOTIC DRILL

    MDR report key: 24268496 · Received February 5, 2026

    Report

    Report Number
    3010266064-2026-00031
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 13, 2026
    Report Date
    March 11, 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. WHEN PROMPTED TO UNLOCK THE DRILL A SYSTEM TIMEOUT OCCURRED. THIS OCCURRED EVERY TIME THE DRILL WAS UNLOCKED. A KPC TEST WAS PERFORMED. THERE IT WAS NOTICED THAT THE BURR COULD NOT BE LOADED. THE DRILL WAS OPENED FOR FURTHER INVESTIGATION. THE THINK PURPLE AND TRANSPARENT WIRES WERE SQUEEZED. THE EXPOSURE MOTOR DIODES WERE MEASURED AND PASSED. A HIPOT TEST WAS PERFORMED WHICH FAILED AS BOTH MOTORS HAD A TO HIGH CURRENT. THE MOTORS WERE REMOVED AND THE DRILL WAS INSPECTED FURTHER. IT WAS NOTICED THAT THE INSIDE OF THE DRILL HAD LIQUID INGRESS AND WAS FULL OF RESIDUE. IT WAS ATTEMPTED TO REMOVE THE CARRIAGE. IT COULD NOT BE PUSHED OUT BY HAND. THE CARRIAGE HAD TO BE PRESSED OUT. THE CARRIAGE WAS COVERED IN A THICK FILM OF RESIDUE. ALOT OF RESIDUE BUILDUP WAS FOUND AROUND THE INTERNAL O-RING 101778. THE CARRIAGE WAS OPENED FOR FURTHER INVESTIGATION. IT WAS FULL OF RESIDUE. THE CARRIAGE WAS DISASSEMBLED FURTHER. BOTH BEARINGS WERE FULL OF RESIDUE AND DID NOT TURN. THE FRONT BEARING HAD BROKEN AND FELL APART WHEN REMOVING THE BEARINGS FROM THE COLLET SHAFT. ALL SEALS WERE INSPECTED. NO DAMAGES OR ABNORMALITIES WERE FOUND. THE HOUSING DISPLAYS NO SIGN THAT THE LIQUID CAME THROUGH THE CABLE AS A RESULT OP THE TORN OF SLIP SHAFT. 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 THIS EVENT IS ASSOCIATED WITH A COMPONENT FAILURE DUE TO LIQUID INGRESS, AS NO OTHER DEFECTS WERE OBSERVED IN THE SEALS AND GASKETS, THE LIQUID INGRESS MAY HAVE BEEN A RESULT OF IMPROPER HANDLING DURING CLEANING AND STERILIZATION ACTIVITIES. ANOTHER CAUSE IS THE RESIDUE BUILDUP AROUND THE CARRIAGE PREVENTING THE DRILL FROM FULLY UNLOCKING. 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, IT WAS NOTICED THAT THE INTERNAL CARRIAGE OF A REAL INTELLIGENCE ROBOTIC DRILL WAS COMPLETELY BLOCKED, AND IT WAS IMPOSSIBLE TO ENGAGE THE BUR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, CHANGING TO A MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327138 REAL INTELLIGENCE ROBOTIC DRILL ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES 00885556757321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ROB10024, SERIAL NUMBER (B)(6).