BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6 4-18 " STEEL MONO V-40

    MDR report key: 3370493 · Received September 26, 2013

    Report

    Report Number
    2210968-2013-24188
    Event Type
    Injury
    Date Received
    September 26, 2013
    Date of Event
    August 30, 2013
    Report Date
    September 6, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS:BATCH GDP150,BATCH GEB726.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT PROCEDURE WITH A MEDIAN STERNOTOMY ON (B)(6) 2013 AND STEEL SUTURE WAS USED. WHEN THE BREAST BONE WAS CLOSED, THE SURGEON DRILLED THE BREAST BONE AND INSERTED SUPER-FIXSORB-MX, (B)(4). THE BREAST BONE AND THE ABSORBABLE FIXATION PLATE WERE FIXED WITH SUTURES. ON (B)(6) 2013, THE SUTURE BECAME LOOSE AND THE PATIENT EXPERIENCED ENSIFORM CARTILAGE DEHISCENCE. THE BODY OF STERNUM ALSO DEHISCED AND CUTTING OF THE BREAST BONE OCCURRED. THEN, DUE TO THE PATIENT¿S COUGH AND OTHER REASONS, THE SUTURE AND THE PLATE WERE SCRAPING EACH OTHER AND THE PLATE GOT STUCK IN THE BREAST BONE. ON (B)(6) 2013, THE PATIENT UNDERWENT A REOPERATION TO REMOVE THE PLATE AND TREAT A PNEUMOTHORAX OF AN UNKNOWN CAUSE. THE SUTURE WAS REMOVED. THE SURGEON PULLED THE PECTORAL MAJOR MUSCLE AND CLOSED THE WOUND WITH NEW SUTURE. THE PATIENT IS STILL IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486708 6 4-18 " STEEL MONO V-40 SUTURE, NON-ABSORBABLE GAQ ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention