BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRASSELER EZX BLADE

    MDR report key: 24177084 · Received January 26, 2026

    Report

    Report Number
    MW5182731
    Event Type
    Injury
    Date Received
    January 26, 2026
    Date of Event
    January 15, 2026
    Report Date
    January 19, 2026
    Manufacturer
    IMEDICOM CO, LTD
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LEFT TOTAL HIP REVISION, BRASSELER EZX BLADE OPENED TO STERILE FIELD. WHILE SURGEON USING INSIDE LEFT HIP BLADE BROKE. ALL PIECES RETRIEVED FROM LEFT HIP. C-ARM WAS OFFERED, BUT SURGEON DETERMINED ALL PIECES RETRIEVED AND NO NEED FOR IMAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240084 BRASSELER EZX BLADE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE IMEDICOM CO, LTD BHA25052708

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention