BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1080-212 ITOTAL IDENTITY IMPACTOR HANDLE

    MDR report key: 16258855 · Received January 27, 2023

    Report

    Report Number
    3004153240-2023-00003
    Event Type
    Malfunction
    Date Received
    January 27, 2023
    Date of Event
    September 13, 2022
    Report Date
    January 26, 2023
    Manufacturer
    CONFORMIS INC
    Product Code
    LXH
    UDI-DI
    00810933030582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL COMPLAINT WAS ISSUED SEPT 13, 2022 A IMPACTOR HANDLE, ED-07827. THE SERIAL WAS 0511662. THIS IS A BLACK RUBBERIZED MODEL OF HANDLE. THE COMPLAINT REPORTS AN IMPACTOR HANDLE, ED-07827, WHICH HAD A SHOULDER SCREWS THAT DISLODGED DURING TIBIAL IMPACTION. THE SCREW FELL INTO A JOINT BUT WAS REMOVED BEFORE CLOSURE. THERE WAS BRIEF DELAY IN SURGERY, BUT NO REPORTED HARM OR INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SET SCREW DISLODGED FROM LOCKING MECHANISM ON THE UNIVERSAL IMPACTOR HANDLE DURING TIBIAL COMPONENT IMPLANTATION AND FELL IN TO THE JOINT. THE SMALL SCREW WAS LOCATED AND REMOVED BEFORE CLOSURE. THERE WAS A BRIEF DELAY AND NO INJURY OR HARM. 1080-212 ITOTAL IDENTITY IMPACTOR HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401185 1080-212 ITOTAL IDENTITY IMPACTOR HANDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CONFORMIS INC 1080-212 0511662 00810933030582

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Required Intervention