BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE NEEDLE , SIDE, 13G 4"

    MDR report key: 3871595 · Received June 13, 2014

    Report

    Report Number
    1526439-2014-11612
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    GAA
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    ALTHOUGH PRODUCT IS NOT BEING RETURNED, THE LOT CODE HAS BEEN PROVIDED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    NO DEVICE EVALUATION COULD BE PERFORMED AS THE SAMPLE WAS NOT RETURNED. A DEVICE HISTORY RECORD REVIEW FOR THE PRODUCT CODE AND LOT NUMBER WAS CONDUCTED, FOUND THE LOT MET SPECIFICATION REQUIREMENTS WHEN RELEASED TO STOCK. A 12 MONTH COMPLAINT TREND ANALYSIS FOR THE PRODUCT CODE FOUND THERE WERE NO RELATED COMPLAINTS. THE ROOT CAUSE FOR THE TIP BREAKING CANNOT BE POSITIVELY IDENTIFIED. HOWEVER IT MAY BE DUE TO UNANTICIPATED FORCES PLACED ON THE TIP DURING THE PROCEDURE. NO CORRECTIVE ACTION/PREVENTIVE ACTION IS REQUIRED AT THIS POINT AS THERE HAS BEEN NO ISSUES IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS DEVICE AND THERE HAS BEEN NO SYSTEMATIC TREND. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS INSERTING A CONFIDENCE SIDE HOLE NEEDLE DURING A VERTEBROPLASTY PROCEDURE AND THE TIP OF THE NEEDLE BROKE OFF IN THE PATIENT¿S PEDICLE. THE SURGEON MENTIONED TO STAFF THAT HE FELT SOME RESISTANCE BUT THERE WAS NOWHERE ELSE FOR HIM TO GO SO HE ADVANCED THE NEEDLE AND THE TIP BROKE. THE TIP OF THE NEEDLE REMAINS IN THE PATIENT. HE WAS ABLE TO FINISH THE PROCEDURE WITH A DIAMOND TIP NEEDLE. SALES REP REPORTS THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO RESULTING DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349656 CONFIDENCE NEEDLE , SIDE, 13G 4" NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA DEPUY SYNTHES SPINE HPNBHT

    Patients

    Seq Age Sex Outcome Treatment
    1