BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE, INTRODUCER NEEDLE, DIAMOND TIP, 11G 6"

    MDR report key: 1675846 · Received April 23, 2010

    Report

    Report Number
    1526439-2010-00062
    Event Type
    Malfunction
    Date Received
    April 23, 2010
    Date of Event
    March 24, 2010
    Report Date
    March 24, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    GAA
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS REPORTED AS HAVING STRONG BONE. EVALUATION OF THE NEEDLE FOUND IT BENT FROM USE AND THE DISTAL END BROKEN OFF. CONTACT REPORTED THAT THE SURGEON HAD USED THE DEVICE AT THREE OTHER LOCATIONS AND THAT IT BROKE THE FOURTH TIME IT WAS INSERTED IN BONE. ROOT CAUSE WAS DUE TO MATERIAL FATIGUE RESULTING FROM THE APPLICATION OF FORCE DURING MULTIPLE USE OF THE NEEDLE. IT IS RECOMMENDED THAT THE DEVICE BE USED ONCE PER CASE AND IS A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    WHILE USING THE CONFIDENCE INTRODUCER NEEDLE, AFTER PLACING THE GUIDEWIRE THROUGH THE OUTER SHEATH OF THE NEEDLE THE USER PULLED OUT THE NEEDLE AND THE NEEDLE TIP (1.25") BROKE OFF IN THE BONE. THE PIECE WAS EMBEDDED IN THE BONE AND HE DID NOT HAVE TO GO TO AN OPEN PROCEDURE. AS AN UNINTENDED PORTION OF THE DEVICE WAS LEFT IN THE BODY AN MDR IS FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIDENCE, INTRODUCER NEEDLE, DIAMOND TIP, 11G 6" INTRODUCER NEEDLE GAA DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK