BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREZS101 EZX UNIVERSAL SHAFT

    MDR report key: 19439863 · Received May 31, 2024

    Report

    Report Number
    2025102-2024-00005
    Event Type
    Injury
    Date Received
    May 31, 2024
    Date of Event
    May 14, 2024
    Report Date
    May 31, 2024
    Manufacturer
    IMEDICOM CO,, LTD
    Product Code
    HWE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE BLADE HOLDER BROKE DURING A TOTAL HIP REVISION. THE BLADE BOUND UP AND BROKE THE BLADE HOLDER ON THE MAIN SHAFT. THE BLADE WAS LEFT IN THE PATIENT. THEY COULD NOT FIND IT AND CONTINUED WITH THE CASE. THEY TOOK AN X-RAY AFTER THE CASE AND SAW THE BLADE ON THE X-RAY BUT COULDN'T FIND IT IN THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308387 BREZS101 EZX UNIVERSAL SHAFT SURGICAL INSTRUMENT HWE IMEDICOM CO,, LTD NIB22021413

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other| R