BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL IDENTITY IMPACTOR HANDLE

    MDR report key: 16878019 · Received May 5, 2023

    Report

    Report Number
    3004153240-2023-00018
    Event Type
    Injury
    Date Received
    May 5, 2023
    Date of Event
    April 20, 2023
    Report Date
    May 3, 2023
    Manufacturer
    CONFORMIS, INC.
    Product Code
    LXH
    Removal / Correction Number
    91376, Z-1133-2023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGERY WAS ABLE TO BE COMPLETED WITHOUT DELAY. THE DEVICE WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WAS CONFIRMED - ONE SCREW WAS ABSENT. THE BUTTON MOVEMENT FELT SMOOTH WITHOUT STICKING OR JAMMING. THE OTHER SCREW WAS REMOVED AND THE DEVICE WAS DISASSEMBLED. NO DAMAGE WAS VISIBLE ON THE INTERNAL MECHANISM. THE DAMAGE IS DETERMINED TO BE ONLY THE MISSING SCREW. THIS OCCURRENCE HAS BEEN REPORTED WITH THE IMPACTOR HANDLE ASSEMBLY ED-07827 (LOT D221301) PREVIOUSLY AND IS BEING MONITORED. A DESIGN CHANGE WAS IMPLEMENTED REMOVING THE SCREWS FROM THE DEVICE TO PREVENT THIS FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SCREW FELL OUT DURING SURGERY ON (B)(6) 2023 AND WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1691606 ITOTAL IDENTITY IMPACTOR HANDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CONFORMIS, INC. D221301

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention