BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMOND NEEDLE WITH THREADED CANNULA

    MDR report key: 927972 · Received March 30, 2007

    Report

    Report Number
    2951580-2007-00002
    Event Type
    Malfunction
    Date Received
    March 30, 2007
    Date of Event
    January 18, 2007
    Report Date
    January 19, 2007
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    KIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BROKEN THREADED CANNULA WAS RETURNED FOR INVESTIGATION. THE THREADED CANNULA WAS ANALYZED FOR MATERIAL MICRO-HARDNESS AND FAILURE MODE. THE MICRO-HARDNESS WAS FOUND TO BE COMPARABLE WITH EXPECTED VALUES FOR A COLD-WORKED 304 STAINLESS CANNULA. IT WAS REPORTED THE INNER STYLET WAS NOT USED DURING THE REMOVAL OF THE THREADED CANNULA AS PROVIDED IN THE INSTRUCTIONS FOR USE AND MAY HAVE CONTRIBUTED TO THE EVENT. THE ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED. THIS MDR WAS PROVIDED INCORRECTLY AS 2951580-2007-00001 ON FEBRUARY 16, 2007 TO THE FDA VIA FAX. THE CORRECT MDR FOR THIS REPORT IS 2951580-2007-00002.

    Description of Event or Problem · 1

    IN 2007, A CLINICAL INCIDENT INVOLVING AN ARTHROCARE THREADED NEEDLE WAS REPORTED TO ARTHROCARE CORP. DURING A BIOPSY PROCEDURE OF THE ILIAC BONE, IT WAS REPORTED THE THREADED CANNULA FRACTURED DURING REMOVAL. IT WAS REPORTED THE INNER STYLET WAS NOT IN PLACE DURING THE REMOVAL. THE PT WAS ADMINISTERED ANTIBIOTICS. THE PT IS REPORTED TO BE DOING WELL. THERE IS NO PLAN TO REOPERATE TO REMOVE THE FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMOND NEEDLE WITH THREADED CANNULA CEMENT DISPENSER KIH ARTHROCARE CORP. NA M200274

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other