BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EF1

    MDR report key: 23824374 · Received December 16, 2025

    Report

    Report Number
    3007593722-2025-00023
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 14, 2025
    Report Date
    December 16, 2025
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    KTT
    UDI-DI
    00810028396029
    PMA / PMN Number
    K113106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING THIS CASE THE DOCTOR REPORTED THAT HE COULD NOT ADVANCE THE SMOOTH OR OLIVE EF1 WIRES DUE TO THEM BEING EXTREMELY DULL. THIS ADDED AT LEAST AN EXTRA 20 MINUTES TO THE CASE AS THEY NEEDED TO BE FORCED INTO THE BONE EVERY TIME THEY WERE IMPLANTED. WAS INVESTIGATED WHERE IT WAS FOUND THAT THERE WAS AN ISSUE WITH EF1 2.0 X 450MM WIRE (DNE-6000-200) THAT WAS FOUND DULL AND HAD DIFFICULTY USING INTRA-OPERATIVELY. THE CURRENT COMPLAINT ALSO INCLUDES EF1 2.0 X 450MM WIRE (DNE-6000-201) WHICH IS A SIMILARLY USED WIRE AND HAS THE SAME FAILURE MODE. PER 7000.010, COMPLAINTS WHICH ARE SIMILAR IN SKU, FAILURE MODE, AND USAGE TO A COMPLAINT THAT HAS ALREADY BEEN INVESTIGATED DO NOT NEED TO BE INVESTIGATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THIS CASE THE DOCTOR REPORTED THAT HE COULD NOT ADVANCE THE SMOOTH OR OLIVE EF1 WIRES DUE TO THEM BEING EXTREMELY DULL. THIS ADDED AT LEAST AN EXTRA 20 MINUTES TO THE CASE AS THEY NEEDED TO BE FORCED INTO THE BONE EVERY TIME THEY WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274343 EF1 WIRE, 2.0 X 450MM, SMOOTH, BAYONET TIP KTT MEDSHAPE, INC. UNKNOWN 00810028396029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other