BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE ROBOTIC DRILL GUARD

    MDR report key: 22552581 · Received July 20, 2025

    Report

    Report Number
    3010266064-2025-00153
    Event Type
    Malfunction
    Date Received
    July 20, 2025
    Date of Event
    July 2, 2025
    Report Date
    September 12, 2025
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757352
    PMA / PMN Number
    K193120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE REAL INTELLIGENCE ROBOTIC DRILL GUARD, PART NUMBER ROB10016, LOT NUMBER 1142802, USED FOR TREATMENT WAS RETURNED FOR EVALUATION. THE REPORTED PROBLEM WAS CONFIRMED WITH A VISUAL INSPECTION. THE SUCTION PORT HAS SEPARATED FROM THE GUARD BODY AND BOTH PIECES WERE RETURNED. A COMPLAINT HISTORY REVIEW WAS PERFORMED BY PART NUMBER AND SIMILAR COMPLAINTS WERE IDENTIFIED. A REVIEW BY LOT/SERIAL NUMBER WAS PERFORMED AND SIMILAR COMPLAINTS WERE IDENTIFIED. A REVIEW OF MANUFACTURING RECORDS INDICATE 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 ESCALATION EVENT REVIEW WAS COMPLETED. THE REVIEW DETERMINED THAT PRIOR ESCALATION ACTIONS ARE APPLICABLE TO THE LOT OR PART NUMBER AND SCOPE OF THIS 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 REPORTED PROBLEM IS A WEAK/INADEQUATE WELD STRENGTH AROUND THE PERIMETER OF THE IRRIGATION TUBE. AS PART OF A CORRECTIVE ACTION A MORE ROBUST DESIGN OF THE DRILL GUARD HAS BEEN RELEASED. THE FAILURE MODE WILL CONTINUE TO BE MONITORED THROUGH COMPLAINT INVESTIGATION AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE: CASE-(B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES TO KNOWN INHERENT DEVICE AND/OR PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, WHILE CUTTING, THE DRILL SUCTION TIP OF A REAL INTELLIGENCE ROBOTIC DRILL GUARD BROKE OFF. ALL PARTS WERE RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737103 REAL INTELLIGENCE ROBOTIC DRILL GUARD ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES UNKNOWN 00885556757352

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown