BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMINI MINIATURE ROBOTIC SYSTEM

    MDR report key: 24861159 · Received April 13, 2026

    Report

    Report Number
    3000719653-2026-00005
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    March 17, 2026
    Report Date
    May 24, 2026
    Manufacturer
    THINK SURGICAL, INC
    Product Code
    OLO
    UDI-DI
    M9461093430
    PMA / PMN Number
    K253661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    DURING INSERTION OF TMINI PINS, THE SURGEON REPORTED THAT THE TMINI PINS WERE SPINNING EVEN WHEN THE DEVICE WAS NOT IN PLANE. THE UNINTENDED SPINNING OF THE PIN 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
    477766 TMINI MINIATURE ROBOTIC SYSTEM ORTHOPEDIC STERIOTAXIC INSTRUMENT OLO THINK SURGICAL, INC 109343 M9461093430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown