BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MMSI FINAL TIGHTENER

    MDR report key: 4915543 · Received July 15, 2015

    Report

    Report Number
    1526439-2015-10622
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    June 20, 2015
    Report Date
    June 20, 2015
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HWR
    PMA / PMN Number
    PEXMEPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED AS THE LOT NUMBER IS UNKNOWN. A TREND ANALYSIS WAS CONDUCTED. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. WITHOUT THE RETURNED OF THE DEVICE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS WERE FOUND, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. SHOULD MORE INFORMATION AND/OR THE SAMPLE BE PROVIDED AT A LATER TIME, THIS COMPLAINT WILL BE REOPENED AND DEVICE EVALUATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE 4 FINAL TIGHTENERS HAVE BROKEN (2 WERE BROKEN FROM THE OUTSET OF THE CASE) TWO BROKE DURING THE CASE WHILST PERFORMING FINAL TIGHTENING. PLEASE CAN 4 X 279712600 BE SENT URGENTLY TO (B)(6) SO THAT THE HOSPITAL CAN CONTINUE OPERATING WITH EXPEDIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459048 MMSI FINAL TIGHTENER DRIVER, PROSTHESIS HWR DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1