BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMINI MINIATURE ROBOTIC SYSTEM

    MDR report key: 21702595 · Received March 26, 2025

    Report

    Report Number
    3000719653-2025-00003
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    February 27, 2025
    Report Date
    March 26, 2025
    Manufacturer
    THINK SURGICAL, INC
    Product Code
    OLO
    UDI-DI
    M9461087570
    PMA / PMN Number
    K243285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A DEMONSTRATION SESSION (NO PATIENT INVOLVEMENT) A CHANGE TO THE SURGICAL PLAN FAILED TO TRANSFER FROM THE NAVIGATION CONSOLE TO THE TMINI ROBOT. ANALYSIS OF THE NAVIGATION CONSOLE LOGS REVELED THE PLAN HAD BEEN MODIFIED THREE TIMES DURING SURGERY, BUT ONLY TWO OF THE FEMORAL CHANGES WERE SUCCESSFULLY TRANSFERRED TO THE TMINI ROBOT. THE THIRD MODIFICATION, WHICH WAS RELATED TO THE TIBIA, WAS CONFIRMED BUT DID NOT TRANSFER TO THE TMINI ROBOT. THIS ISSUE IS RELATED TO A SOFTWARE ANOMALY THAT OCCURS WHEN THE FOLLOWING SEQUENCE OF EVENTS HAPPEN DURING BONE PREPARATION: 1. THE TMINI ROBOT IS MOVED OUT OF THE OPTICAL COMMUNICATION RANGE (FIELD OF VIEW (FOV)). 2. INTRAOPERATIVE CHANGES ARE MADE TO THE PLAN ON THE NAVIGATION CONSOLE. 3. A CHANGE TO THE CUT PLANE IS MADE ON THE TMINI ROBOT USING THE 'SELECT PLANE' BUTTON, WHILE THE ROBOT IS STILL OUT OF FOV. 4. THE TMINI ROBOT IS BROUGHT BACK INTO FOV TO CONTINUE THE PROCEDURE. IN THIS SCENARIO, THE UPDATED PLAN DOES NOT TRANSFER FROM THE NAVIGATION CONSOLE TO THE TMINI ROBOT. THE REQUIREMENT TO ENSURE PROPER PLAN TRANSFER IS DOCUMENTED IN TRAINING AND THE INSTRUCTIONS FOR USE, WHICH INFORM THE USER TO KEEP THE TMINI ROBOT IN THE FOV UNTIL THE PLAN TRANSFERS.

    Description of Event or Problem · 0

    THE SURGEON REVIEWED THE SURGICAL PLAN DURING THE PROCEDURE AND MODIFIED THE POSITIONING OF THE FEMORAL COMPONENT. AFTER COMPLETING THE FEMORAL CUTS, THE SURGEON USED A CALIPER TO VERIFY THE CUTS BEFORE PROCEEDING WITH THE TIBIAL CUTS. ONCE THE FLEXION AND EXTENSION GAPS WERE CAPTURED, THE SURGEON ADJUSTED THE POSITIONING OF THE TIBIAL COMPONENT TO BALANCE THE GAPS. THE TIBIAL PINS WERE THEN PLACED CLOSER TOGETHER. AFTER FINISHING THE TIBIAL CUTS AND VERIFYING THEM WITH A CALIPER, IT WAS OBSERVED THAT THE ALIGNMENT APPEARED VALGUS RATHER THAN THE PLANNED VARUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470370 TMINI MINIATURE ROBOTIC SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO THINK SURGICAL, INC 108757 M9461087570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown