BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED IM NAIL 1.8MM, 50MM, TI

    MDR report key: 23844813 · Received December 18, 2025

    Report

    Report Number
    2031009-2025-00027
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    November 21, 2025
    Report Date
    December 18, 2025
    Manufacturer
    TRIMED, INC.
    Product Code
    HWC
    UDI-DI
    00842188124051
    PMA / PMN Number
    K211783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    SALES MANAGER REPORTED ON (B)(6) 2025 THAT AN IMN1.8-50 T BROKE. THE REP IN THE CASE STATED THAT THE SURGEON REAMED WITH THE APPROPRIATE DRILL PRIOR TO PUTTING IN THE NAIL BEYOND WHERE THE NAIL GOT STUCK. AS HE WAS ADVANCING THE NAIL HE STARTED GETTING RESISTANCE AND TOOK AN X-RAY AND SAW THE NAIL WAS BENDING AND TRIED TO BACK IT OUT AT WHICH POINT THE NAIL BROKE. THE SURGEON SUCCESSFULLY REMOVED ALL PIECES OF THE BROKEN DEVICE AND USED A DIFFERENT NAIL TO COMPLETE THE SURGERY. THE CHANGE IN INVENTORY CAUSED ABOUT A 30-40-MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2387118 THREADED IM NAIL 1.8MM, 50MM, TI IMN1.8-50 T HWC TRIMED, INC. IMN1.8-50 T 00842188124051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other