BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMINI MINIATURE ROBOTIC SYSTEM

    MDR report key: 23587185 · Received November 18, 2025

    Report

    Report Number
    3000719653-2025-00018
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 18, 2025
    Manufacturer
    THINK SURGICAL, INC
    Product Code
    OLO
    UDI-DI
    M9461093430
    PMA / PMN Number
    K252544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INSPECTION OF THE RETURNED TMINI ROBOT, THINK SURGICAL, INC. CONFIRMED THAT ONE OF THE TWO THE NUT TUBES WAS BROKEN AND THE DOWEL PIN WAS MISSING. THE TMINI FUNCTIONED AS INTENDED AS ONLY ONE OF THE NUT TUBES WAS BROKEN. THINK SURGICAL REVIEWED THE DEVICE HISTORY RECORD AND CONFIRMED THERE WAS NO EVIDENCE OF DAMAGE TO THE NUT TUBE DURING PRODUCTION. THERE WAS NO INJURY TO PATIENT, AND THE SURGERY WAS COMPLETED WITHOUT COMPLICATION USING THE TMINI ROBOT. HOWEVER, THINK SURGICAL IS REPORTING THIS INCIDENT BECAUSE IF THE DOWEL PIN DETACHED DURING THE PROCEDURE, IT COULD POSE A RISK OF ENTERING THE SURGICAL INCISION.

    Description of Event or Problem · 0

    THE USER NOTICED PIECES FALLING OUT OF THE TMINI HEAD DURING PRE-OP SET-UP OF THE PRODUCT. DESPITE THIS, THE TMINI ROBOT WAS USED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862336 TMINI MINIATURE ROBOTIC SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO THINK SURGICAL, INC 109343 M9461093430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown