BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 12492876 · Received September 17, 2021

    Report

    Report Number
    2210968-2021-08645
    Event Type
    Injury
    Date Received
    September 17, 2021
    Date of Event
    February 22, 2019
    Report Date
    August 24, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). COMPONENT CODE: (B)(4) DEVICE NOT RETURNED. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS, DEMOGRAPHICS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO CLARIFY THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (ETHIBOND SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OP COMPLICATIONS (HEMATOMA(N=2), WOUND INFECTION(N=1), HEMOTHORAX (N=2), THORACIC OUTLET SYNDROME(N=2)) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (ETHIBOND SUTURE) USED FOR CASES DESCRIBED IN THIS STUDY? IF YES, PLEASE PROVIDE A COMPLETE PATIENT DEMOGRAPHICS FOR PATIENTS WITH POST-OP COMPLICATIONS (HEMATOMA(N=2), WOUND INFECTION(N=1), HEMOTHORAX (N=2), THORACIC OUTLET SYNDROME(N=2))? WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: THORAC CARDIOVASC SURG 2020;68:80¿84.DOI HTTPS://DOI.ORG/10.1055/S-0039-1678695. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    TITLE: QUADRANGULAR FIXATION OF PECTUS BARS TO PREVENT DISPLACEMENT IN NUSS PROCEDURE THE OBJECTIVE OF THIS STUDY WAS TO COMPARE RESULTS OF THE QUADRANGULAR FIXATION PROCEDURE AND THOSE OF THE CLASSIC DOUBLE-BAR FIXATION PROCEDURE IN WHICH BARS WERE SEPARATELY FIXED. FROM SEPTEMBER 2011 TO JANUARY 2016, 86 PATIENTS UNDERWENT THE NUSS PROCEDURE WITH MULTIPLE BARS INSERTION. INSERTION OF THE TWO PECTUS BARS WAS PERFORMED SIMILAR TO THE PROCEDURE OF SINGLE-BAR INSERTION. THE LOWER BAR WAS FIXED ONTO THE ANTERIOR CHEST WALL WITH NO. 5 ETHIBOND (ETHIBOND EXCEL, ETHICON INC.,SOMERVILLE,NEWJERSEY, UNITED STATES) SUTURES. REPORTED COMPLICATIONS INCLUDED HEMATOMA(N=2),WOUND INFECTION(N=1), HEMOTHORAX (N=2), THORACIC OUTLET SYNDROME(N=2). IN CONCLUSION WHEN QUADRANGULAR FIXATION WAS PERFORMED WITH UPPER AND LOWER PECTUS BARS BILATERALLY FIXED BY CONNECTING EACH BAR WITH PLATES, BAR DISPLACEMENT WAS PREVENTED MORE EFFECTIVELY THAN SEPARATE FIXATION, THUS MINIMIZING REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384618 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention