BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMINI MINIATURE ROBOTIC SYSTEM

    MDR report key: 22119531 · Received May 30, 2025

    Report

    Report Number
    3000719653-2025-00005
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    April 29, 2025
    Report Date
    May 30, 2025
    Manufacturer
    THINK SURGICAL, INC
    Product Code
    OLO
    UDI-DI
    M9461087570
    PMA / PMN Number
    K243285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SURGEON REPORTED THE PRESENCE OF A FEMORAL NOTCH OBSERVED ON A POSTOPERATIVE X-RAY FOLLOWING A ROBOT-ASSISTED TOTAL KNEE ARTHROPLASTY. A TECHNICAL INVESTIGATION WAS PERFORMED, INCLUDING REVIEW OF THE TNAV SYSTEM LOG FILES. THE LOGS CONFIRMED THAT THE FINAL IMPLANT PLAN WAS PROPERLY CONFIRMED AND TRANSFERRED TO THE ROBOTIC CUTTING SYSTEM (TMINI). THE PREDICTED ANTERIOR NOTCH IN THE PLAN WAS MINIMAL (APPROX. 0.9 MM) A WARNING IS PRESENTED TO THE USER FOR NOTCHES ABOVE 1MM, AND THERE WAS NO LOG EVIDENCE OF A LARGER NOTCH BEING PLANNED OR PRESENTED. REGISTRATION CONFIDENCE WAS WITHIN ACCEPTABLE LIMITS THROUGHOUT THE CASE. THE SOFTWARE FUNCTIONED AS INTENDED DURING PLAN FINALIZATION AND DATA TRANSFER; HOWEVER, THE REPORTED ABSENCE OF A CONFIRMATION SCREEN MAY INDICATE A POTENTIAL USER INTERFACE ANOMALY. ALTHOUGH THE SYSTEM DID NOT PRESENT A PLAN WITH A 5 MM NOTCH, A DEEPER THAN EXPECTED NOTCH OCCURRED DURING RESECTION. THE INSTRUMENTATION USED DURING THE MANUAL PORTION OF THE PROCEDURE (IMPROPER PLACEMENT OF CUTTING GUIDE, EXCESSIVE SAW ANGULATION, OR MANUAL CUTS) CAN LEAD TO FEMORAL NOTCHING. AS OF THE DATE OF THIS REPORT, NO ADVERSE PATIENT OUTCOMES OR MEDICAL INTERVENTIONS HAVE BEEN REPORTED. NONETHELESS, DUE TO THE POTENTIAL USER INTERFACE ANOMALY AND THE PRESENCE OF A POSTOPERATIVE CONDITION (FEMORAL NOTCH) THINK SURGICAL DECIDED TO REPORT THIS EVENT.

    Description of Event or Problem · 0

    THE SURGEON REPORTED FEMORAL NOTCHING WAS OBSERVED ON THE POST-OP X-RAY. THE SURGEON STATED THAT A NOTCH WARNING APPEARED ON SCREEN DURING GAP ASSESSMENT BUT WAS RESOLVED AFTER MAKING NECESSARY FEMORAL IMPLANT POSITION ADJUSTMENTS. HE NOTED THAT AFTER SAVING THE ADJUSTMENTS, THE EXPECTED CONFIRMATION SCREEN DID NOT APPEAR. THE CASE WAS COMPLETED ROBOTICALLY, AND A VISIBLE FEMORAL NOTCH WAS OBSERVED AFTER COMPLETING THE 4-IN-1 FEMORAL CUTS. THE NOTCH WAS CONSEQUENTLY CONFIRMED WITH THE POST-OP X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844373 TMINI MINIATURE ROBOTIC SYSTEM ORTHOPEDIC STEROTAXIC INSTRUMENT OLO THINK SURGICAL, INC 108757 M9461087570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown