BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSOLUTION ONE TOTAL KNEE APPLICATION

    MDR report key: 14948022 · Received July 7, 2022

    Report

    Report Number
    3000719653-2019-00001
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    July 12, 2019
    Report Date
    July 7, 2022
    Manufacturer
    THINK SURGICAL INC.
    Product Code
    OLO
    PMA / PMN Number
    K191369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING REMOVAL OF FIXATION PINS AFTER SURGERY WAS COMPLETED, THE FEMUR FIXATION PIN SNAPPED OFF BY THE THREADS. THE BROKEN END OF PIN WAS SUCCESSFULLY REMOVED FROM THE PATIENT.UNDER MAGNIFICATION THERE DOES NOT APPEAR TO BE ANY MATERIAL DEFECTS AT THE LOCATION OF THE BREAK, SUCH AS AIR POCKETS OR HAIRLINE CRACKS AND THE PIN DOES NOT APPEAR TO BE BENT OR DEFORMED. THE PIN WAS REMOVED WITH A BROKEN SCREW REMOVAL KIT AND NEEDLE NOSE PLIERS. THE PIN WAS REMOVED SUCCESSFULLY WITHOUT ADDITIONAL INTERVENTION. NO FURTHER CORRECTIVE ACTION IS NECESSARY. WE WILL MONITOR VIA THE COMPLAINT PROCESS FOR ADDITIONAL INSTANCES OF BROKEN PINS AND WILL TAKE ACTION AS WARRANTED.

    Description of Event or Problem · 0

    DURING REMOVAL OF FIXATION PINS AFTER SURGERY WAS COMPLETED, THE FEMUR FIXATION PIN WAS BEING REMOVED BY HAND WITH OUR T-HANDLE WRENCH 101884 AND SNAPPED OFF BY THE THREADS. THE BROKEN END OF PIN WAS SUCCESSFULLY REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598514 TSOLUTION ONE TOTAL KNEE APPLICATION TCAT OLO THINK SURGICAL INC. 103306 12091

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown