BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE INTRO NEEDLE, DIA, 10G 5

    MDR report key: 2877228 · Received December 18, 2012

    Report

    Report Number
    1526439-2012-00302
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    GAA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT TREND ANALYSIS FOUND NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS PRODUCT CODE. THE DEVICE HISTORY RECORDS HAVE BEEN REQUESTED. WE ANTICIPATE THE LOT WAS RELEASED MEETING SPECIFICATION REQUIREMENTS. A FOLLOW UP REPORT WILL BE SUBMITTED IF ANY DISCREPANCIES ARE FOUND. COMPLAINT DATA IS REVIEWED MONTHLY VIA THE SPINE MONTHLY COMPLAINT REVIEW MEETING TO IDENTIFY AND INITIATION ACTION AGAINST ANY EMERGING TRENDS; THE MEETING INCLUDES CROSS-FUNCTIONAL REPRESENTATION FROM RD, QUALITY ENGINEERING, CLINICAL RESEARCH, AND COMPLAINT HANDLING TO ENSURE A ROBUST REVIEW. WITHOUT A PRODUCT SAMPLE, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. IN THE ABSENCE OF A PRODUCT SAMPLE OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT PRODUCT SAMPLE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND THE PRODUCT EVALUATED. DEVICE EVALUATED BY MFR: DISCARDED BY CUSTOMER.

    Description of Event or Problem · 1

    THE JAM SHIDI NEEDLE WAS PLACED IN THE L4 PEDICLE. DURING REMOVAL OF THE NEEDLE, THE HANDLE BROKE. AFTER USING PLIERS AND VARIOUS INSTRUMENTS TO EXTRACT THE REMAINING PORTION OF THE NEEDLE, A SMALL PIECE WAS REMOVED BUT THE REMAINING PIECE OF THE NEEDLE REMAINS IN THE L4 PEDICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIDENCE INTRO NEEDLE, DIA, 10G 5 NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA DEPUY RAYNHAM HNJBFT

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR