BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENGAGE SURGICAL PARTIAL KNEE SYSTEM

    MDR report key: 11821281 · Received May 13, 2021

    Report

    Report Number
    3016249968-2021-00004
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 13, 2021
    Report Date
    May 13, 2021
    Manufacturer
    ENGAGE UNI LLC (DBA ENGAGE SURGICAL)
    Product Code
    NJD
    UDI-DI
    B6951500610020
    PMA / PMN Number
    K190439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON INDICATED THAT DURING THE PROCEDURE IT WAS EVIDENT THE PATIENT HAD UNUSUALLY DENSE SCLEROTIC BONE IN THE AREA OF IMPLANTATION. REVIEW OF PRE-OP IMAGING CONFIRMED THIS. THE AREA OF HIGH-DENSITY BONE MAY HAVE RESULTED IN HIGHER THAN NORMAL IMPACTION FORCES BEING APPLIED TO THE INSTRUMENTS DURING THE IMPLANTATION OF THE TIBIAL ANCHOR. THE HIGHER FORCES MAY HAVE CAUSED THE TIP OF THE TIBIAL ANCHOR GUIDE SCREW TO DETACH. THE TIBIAL ANCHOR GUIDE WAS RETURNED AND EVALUATED. THERE WAS NO VISIBLE DEFECTS OR FLAWS IN THE INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF A TIBIAL ANCHOR GUIDE SCREW BROKE OFF WHILE IMPACTING THE TIBIAL ANCHOR IMPLANT INTO THE TIBIA. THE TIBIAL ANCHOR IMPLANTATION WAS COMPLETED SUCCESSFULLY. THE SURGEON LEFT THE TIP OF THE SCREW IN THE TIBIAL TRAY IMPLANT, AS IT WAS FULLY CONTAINED INSIDE THE MATING THREADED AREA OF THE TIBIAL TRAY COMPONENT. NO SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE CONSEQUENCES FROM THE EVENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719894 ENGAGE SURGICAL PARTIAL KNEE SYSTEM TIBIAL ANCHOR GUIDE INSTRUMENT NJD ENGAGE UNI LLC (DBA ENGAGE SURGICAL) 1-50061-002 200144 B6951500610020

    Patients

    Seq Age Sex Outcome Treatment
    1