BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE BIOPSY NEEDLE

    MDR report key: 18002642 · Received October 25, 2023

    Report

    Report Number
    18002642
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    October 2, 2023
    Report Date
    October 16, 2023
    Manufacturer
    IZI MEDICAL PRODUCTS, LLC
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING THE BIOPSY, THE METAL SHAFT OF THE OUTER CANNULA BROKE CLEANLY INTO TWO PIECES, EMBEDDED WITHIN THE RIGHT ILIAC CREST. THIS OCCURRED WHILE ADVANCING AND TORQUING THE NEEDLE FOR THE CORE SAMPLE OF A BONE MARROW BIOPSY. ATTEMPT TO MANUALLY EXTRACT THE BROKEN EMBEDDED FRAGMENT, VIA A SLIGHTLY LARGER INCISION AND BLUNT DISSECTION WITH A KELLY CLAMP. REMOVAL WAS UNSUCCESSFUL DUE TO THE RETAINED FRAGMENT BEING PERFECTLY FLUSH WITH THE ILIAC CORTEX AND NOTHING TO GRASP ONTO. THE REMNANT WAS LEFT IN PLACE RATHER THAN PERFORM A MORE INVASIVE AND HIGHER-RISK PROCEDURE TO EXTRACT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675344 BONE BIOPSY NEEDLE INSTRUMENT, BIOPSY KNW IZI MEDICAL PRODUCTS, LLC G12373 - DBBN-11-10.0 FP231274

    Patients

    Seq Age Sex Outcome Treatment
    1 29930 DA Male