BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER EZX BLADE

    MDR report key: 24636771 · Received March 19, 2026

    Report

    Report Number
    3009599228-2026-00001
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    January 15, 2026
    Report Date
    March 20, 2026
    Manufacturer
    IMEDICOM CO., LTD.
    Product Code
    HWE
    UDI-DI
    00887919859130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING MEDWATCH REPORT MW5182731 VIA OUR U.S. AGENT, WE REQUESTED ADDITIONAL INFORMATION FROM THE IMPORTER. HOWEVER, NO FURTHER DETAILS HAVE BEEN PROVIDED TO DATE. ALTHOUGH NO PATIENT INJURY WAS REPORTED, DEVICE RETRIEVAL HAS BEEN REQUESTED FOR EVALUATION.

    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
    195961 BRASSELER EZX BLADE INSTRUMENT, SURGICAL, ORTHOPEDIC HWE IMEDICOM CO., LTD. BRXTB530 BHA25052708 00887919859130

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention