BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONOPTY BONE BIOPSY SYSTEM

    MDR report key: 3983587 · Received August 1, 2014

    Report

    Report Number
    MW5037629
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 25, 2014
    Manufacturer
    APRIOMED INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING A BIOPSY OF RIGHT TIBIAL LESION USING APRIOMED 12G BONOPTY BONE BIOPSY SYSTEM UNDER RADIOLOGIC IMAGING. POST BIOPSY, AS THE OUTER CANNULA WAS PULLED THE HUB BROKE. IN THE ATTEMPT TO REMOVE THE REMAINING PORTION OF THE CANNULA, THE TIP OF THE CANNULA BROKE OFF AND REMAINED WITHIN THE TIBIA. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS DISCHARGED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451607 BONOPTY BONE BIOPSY SYSTEM BONE BIOPSY KIT KNW APRIOMED INC. 134914

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR