BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 19047768 · Received April 4, 2024

    Report

    Report Number
    2210968-2024-03909
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    July 27, 2022
    Report Date
    April 4, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED (VICRYL & ETHIBOND SUTURE) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS: GRAFT RUPTURE, DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS (VICRYL & ETHIBOND SUTURE) USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WHICH SPECIFIC ETHICON PRODUCTS (VICRYL & ETHIBOND SUTURE) HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? PATIENT DEMOGRAPHICS? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. NO PRODUCT AVAILABLE FOR RETURN. CITATION: HTTPS://DOI.ORG/10.1016/J.ASMR.2022.07.010. NOTE: EVENTS REPORTED ON MW# 2210968-2024-03908, MW# 2210968-2024-03909. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 · 0

    TITLE: THE USE OF FIVE-STRAND HAMSTRING AUTOGRAFT TO INCREASE THE GRAFT SIZE IN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTIONDA PROSPECTIVE COHORT STUDY WITH SATISFACTORY EARLY CLINICAL RESULTS. THE AIM OF THE STUDY IS TO REPORT ON THE OUTCOMES OF USING 5-STRAND HAMSTRING AUTOGRAFT TO INCREASE THE GRAFT SIZE FOR ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION AND TO DETERMINE WHETHER THE CLINICAL RESULTS ARE COMPARABLE TO USING CONVENTIONAL 4-STRAND GRAFT. A PROSPECTIVE COHORT STUDY OF PATIENTS WITH ARTHROSCOPIC-ASSISTED SINGLE-BUNDLE ACL RECONSTRUCTION USING HAMSTRING AUTOGRAFT FROM (B)(6) 2021. 45 PATIENTS WERE INCLUDED INTO THE STUDY. 2-0 VICRYL SUTURES (ETHICON) WAS USED IN THE 5-STRAND GRAFT FOR FURTHER REINFORCEMENT AND THE GRACILIS AND SEMITENDINOSUS WERE LOOPED AROUND A NONABSORBABLE SUTURE (ETHIBOND NO. 5) TO FORM A QUADRUPLED HAMSTRING GRAFT. REPORTED COMPLICATION IS GRAFT RUPTURE (4.8%) IN THE 4-STRAND GROUP. IN CONCLUSION, THE 5- STRAND HAMSTRING GRAFT TECHNIQUE PROVIDES A GRAFT WITH SIGNIFICANTLY LARGER GRAFT DIAMETER THAN THE QUADRUPLED GRAFT TECHNIQUE, WITH SATISFACTORY SHORT- TO MEDIUM-TERM OUTCOMES. THE 5-STRAND GRAFT IS THEREFORE A USEFUL TECHNIQUE TO INCREASE THE GRAFT SIZE WHEN FACED WITH THE PROBLEM OF SMALL HAMSTRING GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58233 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention