BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMINI MINIATURE ROBOTIC SYSTEM

    MDR report key: 23248720 · Received October 8, 2025

    Report

    Report Number
    3000719653-2025-00011
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    July 10, 2025
    Report Date
    April 15, 2026
    Manufacturer
    THINK SURGICAL, INC
    Product Code
    OLO
    UDI-DI
    M9461093430
    PMA / PMN Number
    K250877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THINK SURGICAL, INC. IS ACTIVELY INVESTIGATING THE SOURCE OF THE BLACK MATERIAL. OUR SYSTEM DOES NOT USE LUBRICANTS, AND THE SUBSTANCE IS NOT PART OF OUR APPROVED MATERIALS. CYTOTOXICITY TESTING WAS PERFORMED ON THE MATERIAL, AND THE RESULTS INDICATE IT IS NON-CYTOTOXIC. HOWEVER, INVESTIGATING THE COMPOSITION AND ORIGIN OF THE MATERIAL IS ON-GOING A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL FINDINGS ARE AVAILABLE. NO PATIENTS HAVE BEEN EXPOSED TO THE BLACK MATERIAL.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT SUMMARIZES THE RESULTS OF THE MANUFACTURER'S INVESTIGATION INTO THE ISSUE OF TMINI PINS NOT SPINNING WITHIN THE CHUCK AND THE OBSERVATION OF BLACK MATERIAL ON THE END OF THE PIN ASSOCIATED WITH TMINI SYSTEM SERIAL NUMBER (B)(6). THE EVENT WAS REPORTED TO HAVE OCCURRED ON JULY 10, 2025 AND WAS IDENTIFIED AND REPORTED TO THE MANUFACTURER ON JULY 31, 2025. THE ISSUE WAS IDENTIFIED PRIOR TO DEVICE USE ON THE PATIENT, AND NO PATIENT EXPOSURE OCCURRED. THE EVENT DATE REFLECTS THE ESTIMATED DATE OF OCCURRENCE BASED ON AVAILABLE INFORMATION. NO LOG FILE ERRORS WERE IDENTIFIED FOR (B)(6). RETURNED DEVICE EVALUATION CONFIRMED A FRACTURE OF THE CHUCK COMPONENT, REPRESENTING A MECHANICAL FAILURE, AND THE PRESENCE OF BLACK RESIDUE WITHIN THE CHUCK SOCKET. THE UNDERLYING CAUSE OF THE FRACTURE COULD NOT BE DETERMINED. ENGINEERING ASSESSMENT DETERMINED THAT THE RESIDUE DID NOT CONTRIBUTE TO THE MECHANICAL FAILURE, AND THE MECHANICAL FAILURE DID NOT CONTRIBUTE TO THE PRESENCE OF THE RESIDUE. ANALYTICAL AND BIOLOGICAL TESTING (FTIR, SEM/EDS, RAMAN, AND CYTOTOXICITY) DEMONSTRATED THAT THE RESIDUE IS NON-CYTOTOXIC AND CONSISTENT WITH LOW-TOXICITY, TRIGLYCERIDE-LIKE SUBSTANCES AND/OR MACHINING OIL RESIDUES. INDEPENDENT REVIEW CONCLUDED THE MATERIAL IS MOST CONSISTENT WITH AN ALIPHATIC ESTER WITH POTENTIAL SOURCES INCLUDING MANUFACTURING RESIDUES. A HEALTH HAZARD EVALUATION DETERMINED THAT THE RESIDUE PRESENTS NEGLIGIBLE RISK BASED ON NON-CYTOTOXICITY, MATERIAL CHARACTERIZATION, LACK OF DIRECT PATIENT CONTACT, ABSENCE OF REPORTED PATIENT HARM, AND LOW OCCURRENCE RATE. NO ADDITIONAL BIOLOGICAL TESTING WAS WARRANTED. THE ISSUE WAS IDENTIFIED PRIOR TO DEVICE USE ON THE PATIENT, AND THE TMINI SYSTEM WAS NOT USED. THE PROCEDURE WAS COMPLETED MANUALLY. THIS FAILURE MODE IS IDENTIFIED IN THE RISK MANAGEMENT FILE, INCLUDING INSUFFICIENT TORQUE TRANSMISSION AND ATTITUDE DRIVE TRAIN-RELATED FAILURE MODES. ASSOCIATED HARMS ARE ASSESSED AS NO PLAUSIBLE HARM OR SUBOPTIMAL PROCEDURAL OUTCOME, AND RESIDUAL RISK WAS EVALUATED IN ACCORDANCE WITH ESTABLISHED RISK MANAGEMENT PROCEDURES AND DETERMINED TO BE ACCEPTABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2025 THE THINK SURGICAL EMPLOYEE IDENTIFIED THAT THE TMINI PINS WERE NOT SPINNING INSIDE THE TMINI CHUCK. UPON INSPECTION, BLACK GREASE LIKE MATERIAL WAS OBSERVED ON THE END OF THE PIN THAT HAD BEEN IN THE CHUCK. THE TMINI SYSTEM WAS NOT USED, AND THE PATIENT WAS NOT EXPOSED AS THE ISSUE WAS DISCOVERED PRIOR TO USE.

    Description of Event or Problem · 0

    ON 7/31/2025 THE THINK SURGICAL EMPLOYEE IDENTIFIED THAT THE TMINI PINS WERE NOT SPINNING INSIDE THE TMINI CHUCK. UPON INSPECTION, BLACK GREASE LIKE MATERIAL WAS OBSERVED ON THE END OF THE PIN THAT HAD BEEN IN THE CHUCK. THE TMINI SYSTEM WAS NOT USED, AND THE PATIENT WAS NOT EXPOSED AS THE ISSUE WAS DISCOVERED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412019 TMINI MINIATURE ROBOTIC SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO THINK SURGICAL, INC 109343 M9461093430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown