BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMINI MINIATURE ROBOTIC SYSTEM

    MDR report key: 21971422 · Received May 6, 2025

    Report

    Report Number
    3000719653-2025-00004
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    April 7, 2025
    Report Date
    May 6, 2025
    Manufacturer
    THINK SURGICAL, INC
    Product Code
    OLO
    UDI-DI
    M9461093430
    PMA / PMN Number
    K243285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SYSTEM LOGS CONFIRM THAT REGISTRATION WAS COMPLETED CORRECTLY AND WITHOUT ERROR. DURING THE PROCEDURE, THE SURGEON ENCOUNTERED DIFFICULTY DURING PIN INSERTION AND USED A MALLET, WHICH IS STANDARD IN MANUAL TKA BUT CAN AFFECT PIN ALIGNMENT IN ROBOTIC-ASSISTED PROCEDURES. THE THINK SURGICAL REPRESENTATIVE INFORMED THE SURGEON THAT THIS TECHNIQUE COULD COMPROMISE THE PIN PLANE AND, IN TURN, AFFECT CUT ACCURACY. IN THE SECOND ATTEMPT, THE MEDIAL PIN WAS PLACED IN THE SAME LOCATION AS THE INITIAL ATTEMPT, POSSIBLY DUE TO SPATIAL CONSTRAINTS IN THE OPERATIVE FIELD. REUSING THE ORIGINAL PIN HOLE, PARTICULARLY IF IT HAD BEEN ALTERED DURING THE INITIAL PLACEMENT, COULD CONTRIBUTE TO PERSISTENT INACCURACY. POST-CUT VERIFICATION WITH THE DIGITIZER REVEALED A 2 MM DEVIATION LATERALLY. THIS IS WITHIN THE ACCURACY SPECIFICATIONS OF THE TMINI SYSTEM, BUT THE SURGEON OPTED TO MANUALLY ADJUST THE CUT USING A SAW. FINAL VERIFICATION USING BOTH THE DIGITIZER AND THE GAP ASSESSMENT TOOL CONFIRMED AN ACCURATE RESECTION. NO PATIENT INJURY OR ADVERSE OUTCOME WAS REPORTED. THE MOST PROBABLE ROOT CAUSE WAS TECHNIQUE-RELATED - SPECIFICALLY, THE USE OF A MALLET FOR PIN INSERTION AND REUSE OF AN ALTERED PIN HOLE, BOTH OF WHICH MAY HAVE CONTRIBUTED TO MINOR DEVIATION IN THE CUT PLANE.

    Description of Event or Problem · 0

    DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE USING TMINI SYSTEM, THE TIBIAL CUT APPEARED TO DEVIATE BY APPROXIMATELY 2MM. THE SURGEON ENCOUNTERED RESISTANCE DURING PIN INSERTION AND USED MALLET TO ASSIST, AS COMMONLY DONE IN MANUAL TKA PROCEDURES. A THINK SURGICAL REPRESENTATIVE PRESENT AT THE TIME ADVISED THAT USING A MALLET COULD IMPACT THE ACCURACY OF THE PIN PLANE. FOLLOWING THE TIBIAL CUT, THE SURGEON VERIFIED RESECTION USING THE DIGITIZER AND NOTED THE LATERAL SIDE WAS 3MM PROUD. AFTER CONSULTING WITH THE THINK SURGICAL REPRESENTATIVE, THE SURGEON DECIDED TO REPOSITION THE PINS AND PERFORM A RECUT USING THE TMINI SYSTEM. THE MEDIAL PIN WAS INSERTED IN THE SAME HOLE AS THE PREVIOUS PLACEMENT, WHILE THE LATERAL PIN WAS POSITIONED IN A NEW LOCATION. AFTER THE SECOND CUT, VERIFICATION WITH THE DIGITIZER SHOWED A 2MM DISCREPANCY. THE SURGEON THEN MANUALLY ADJUSTED THE LATERAL SIDE USING A SAW AND VERIFIED THE RESULT USING BOTH THE DIGITIZER AND THE TMINI GAP ASSESSMENT SCREEN. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT ANY REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2010957 TMINI MINIATURE ROBOTIC SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO THINK SURGICAL, INC 109343 M9461093430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown