BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EF1

    MDR report key: 23129426 · Received September 23, 2025

    Report

    Report Number
    3007593722-2025-00017
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    August 27, 2025
    Report Date
    September 23, 2025
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    KTT
    PMA / PMN Number
    K113106
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT NEW EF1 NUTS UTILIZED IN CASE YESTERDAY CAUSING BOLT BREAKAGE, PATIENT WILL NEED A SECOND PROCEDURE TO FIX BREAKAGE. A CAPA WAS OPENED TO DOCUMENT THE INVESTIGATION AND CORRECTIVE ACTION INTO COMPLAINTS OF THE 10MM NUT (DNE-6000-036) COLD WELDING/GALLING TO THE WIRE FIXATION BOLT AND HALF PIN FIXATION BOLT. CORRECTIVE ACTION WAS IMPLEMENTED JULY 2, 2025. THIS IS THE SECOND COMPLAINT ASSOCIATED WITH THE REVISED DNE-6000-036. THE EFFECTIVENESS VERIFICATION INDICATES A 75% REDUCTION IN COMPLAINTS ASSOCIATED WITH THE 10MM NUT NOT MAINTAINING FRAME ASSEMBLY OVER A 6-MONTH TIMEFRAME. EFFECTIVENESS WILL BE TRACKED AND DOCUMENTED WITHIN CAPA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEW EF1 NUTS UTILIZED IN CASE YESTERDAY CAUSING BOLT BREAKAGE, PATIENT WILL NEED A SECOND PROCEDURE TO FIX BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200596 EF1 NUT - 10MM KTT MEDSHAPE, INC. 6588-3

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other