BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEEL

    MDR report key: 7316650 · Received March 6, 2018

    Report

    Report Number
    9612501-2018-00324
    Event Type
    Malfunction
    Date Received
    March 6, 2018
    Date of Event
    January 23, 2017
    Report Date
    March 4, 2018
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAQ
    UDI-DI
    20884521102573
    PMA / PMN Number
    K955723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS PREVIOUSLY SUBMITTED ON A SUMMARY REPORT. SUBSEQUENTLY, MEDTRONIC HAS RECEIVED ADDITIONAL INFORMATION WHICH IS BEING SUBMITTED VIA THIS 3500A. EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF FOUR DEVICES. THE VISUAL INSPECTION AND FUNCTIONAL EVALUATION OF THE SAMPLE HAD ACCEPTABLE RESULTS. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PRODUCT WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: OCCURRED DURING STERNUM CLOSURE. THE DEVICE BROKE AT THE SWAGE OF THE NEEDLE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160114 STEEL SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE GAQ DAVIS & GECK CARIBE LTD 88862410-69 D6K0755X 20884521102573

    Patients

    Seq Age Sex Outcome Treatment
    1