BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMINI MINIATURE ROBOTIC SYSTEM

    MDR report key: 23493182 · Received November 6, 2025

    Report

    Report Number
    3000719653-2025-00015
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    October 6, 2025
    Report Date
    November 4, 2025
    Manufacturer
    THINK SURGICAL, INC
    Product Code
    OLO
    UDI-DI
    M9461090040
    PMA / PMN Number
    K250877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INSPECTION OF THE RETURNED TIBIAL ARRAY, THINK SURGICAL, INC. CONFIRMED THAT ONE SCREW SECURING THE TOP OF THE CASE WAS LOOSE. EXAMINATION OF THE SCREW AND THREADED HOLE REVEALED NO DAMAGE, AND A UV LIGHT INSPECTION SHOWED NO EVIDENCE OF ADHESIVE RESIDUE. THINK SURGICAL CONTACTED THE ARRAY'S SUPPLIER TO VERIFY WHETHER LOCTITE (THREAD LOCKING ADHESIVE) IS USED ON THIS SCREW. THE SUPPLIER CONFIRMED THAT THE LOCTITE IS NOT APPLIED TO THE SCREW THAT SECURES THE TOP CASE, ALTHOUGH IT IS USED ON OTHER SCREWS WITHIN THE ASSEMBLY. THE ABSENCE OF THE ADHESIVE ON THIS PARTICULAR SCREW MAY HAVE ALLOWED IT TO LOOSEN AND FALL OUT OVER TIME. THERE WAS NO INJURY TO PATIENT, AND THE SURGERY WAS COMPLETED WITHOUT COMPLICATION USING THE TRACKING ARRAY. HOWEVER, THINK SURGICAL IS REPORTING THIS INCIDENT BECAUSE THE SCREW DETACHED DURING THE PROCEDURE, AND IT COULD POSE A RISK OF ENTERING THE SURGICAL INCISION.

    Description of Event or Problem · 0

    THE USER NOTICED A SCREW FALL OUT OF THE TIBIAL ARRAY DURING TIBIAL RESECTION. DESPITE THIS, THE SCREW WAS REMOVED FROM THE SURGICAL FIELD, AND THE ARRAY WAS USED SUCCESSFULLY DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1924352 TMINI MINIATURE ROBOTIC SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO THINK SURGICAL, INC 109004 M9461090040

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown