BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMINI MINIATURE ROBOTIC SYSTEM

    MDR report key: 23796494 · Received December 12, 2025

    Report

    Report Number
    3000719653-2025-00020
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 17, 2025
    Report Date
    December 12, 2025
    Manufacturer
    THINK SURGICAL, INC
    Product Code
    OLO
    UDI-DI
    M9461093430
    PMA / PMN Number
    K252544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. UPON INSPECTION THE TRIGGER WAS REMOVED, AND THE SPRING CLIP WAS OBSERVED TO BE BENT. THE DEFORMATION OF THE TRIGGER SPRING CLIP CAUSED INCREASED DOWNWARD FORCE ON THE TRIGGER, RESULTING IN THE FRICTION AND INTERFERENCE BETWEEN COMPONENTS. THIS MECHANICAL INTERFERENCE COULD PREVENT THE TRIGGER FROM RETURNING TO ITS NATURAL POSITION, LEADING TO THE REPORTED JAMMING. THE OBSERVED CONDITION IS CONSISTENT WITH THE REPORTED EVENT. THE SURGERY WAS COMPLETED WITHOUT COMPLICATION, AND NO INJURIES WERE REPORTED.

    Description of Event or Problem · 0

    DURING INSERTION OF DISTAL FEMORAL PINS, THE SURGEON REPORTED THAT THE MINI TRIGGER WAS STUCK IN THE ACTIVATED POSITION AND WOULD NOT RETURN TO THE OFF POSITION AS EXPECTED. THE JAMMED TMINI TRIGGER COULD RESULT IN UNINTENDED SPINNING OF THE PIN, WHICH PRESENTS A POTENTIAL RISK OF USER OR PATIENT INJURY DUE TO LOSS OF CONTROL OF THE PIN OR UNINTENDED TISSUE CONTACT. THE PROCEDURE WAS COMPLETED USING THE TMINI SYSTEM, AND NO INJURY TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2711916 TMINI MINIATURE ROBOTIC SYSTEM ORTHOPEDIC STERIOTAXIC INSTRUMENT OLO THINK SURGICAL, INC 109343 M9461093430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown