BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 9536269 · Received December 31, 2019

    Report

    Report Number
    2210968-2019-91424
    Event Type
    Injury
    Date Received
    December 31, 2019
    Report Date
    December 9, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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 REGARDING THE ADDITIONAL EVENTS. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: JBONE JOINT SUIG AM. 2011; 93: 1865-72. DOI: HTTP://DX.DOI.ORG/10.2106/JBJS.K.00136. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: OUTCOMES AND SECOND-LOOK ARTHROSCOPIC EVALUATION AFTER DOUBLE-BUNDLE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH USE OF A SINGLE TIBIAL TUNNEL". AUTHOR/S: JIN HWAN AHN, MD, SANG-HEE CHOI, MD, JOON HO WANG, MD, JAE CHUL YOO, MD, HYUN SEOK TIM, MD, AND MOON JONG CHANG, MD. CITATION: JBONE JOINT SUIG AM. 2011; 93: 1865-72. DOI: HTTP://DX.DOI.ORG/10.2106/JBJS.K.00136. THE CORRELATION BETWEEN GRAFT APPEARANCE AND CLINICAL OUTCOME AFTER DOUBLE-BUNDLE ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION IS A MAJOR CONCERN. IN THIS STUDY, THE GRAFT APPEARANCE WAS ASSESSED WITH USE OF SECOND LOOK ARTHROSCOPY AND WAS CORRELATED WITH THE CLINICAL OUTCOME. A TOTAL OF 37 KNEES THAT UNDERWENT SECOND-LOOK ARTHROSCOPY AFTER DOUBLE-BUNDLE ACL RECONSTRUCTION AND 62 KNEES THAT UNDERWENT DOUBLE-BUNDLE ACL RECONSTRUCTION WITHOUT SUBSEQUENT SECOND-LOOK ARTHROSCOPY (99 PATIENTS; WERE INCLUDED IN THIS RETROSPECTIVE STUDY. DURING THE SURGICAL PROCEDURE, A 2-CM TRANSVERSE INCISION IS THEN MADE JUST POSTERIOR AND PROXIMAL TO THE LATERAL EPICONDYLE OF THE FEMUR, AND THE SLEEVES OF A RIGIDFIX BIO ABSORBABLE PIN (ETHICON) ARE INTRODUCED THROUGH THIS INCISION. THE AUTHORS USED A WE USED A MINIPLATE WITH 2 HOLES AND ETHIBOND 2-0 SUTURES (ETHICON). ACCORDING TO THE LENGTH OF THE POSTEROLATERAL FEMORAL TUNNEL, THE MINIPLATE IS TIED WITH THE ETHIBOND 2-0 SUTURES (ETHICON) TO PLACE A 20-MM LENGTH OF AUTOGENOUS TENDON PORTION WITHIN THE TUNNEL. REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE INFECTION (N-1) WHICH REQUIRED ANTIBIOTIC TREATMENT. IN CONCLUSION, IN THE PRESENT STUDY, THE AUTHORS OBSERVED THAT THE CLINICAL OUTCOMES WITH DOUBLE-BUNDLE ACL RECONSTRUCTION WERE AS SATISFACTORY WITH USE OF A SINGLE TIBIAL TUNNEL AS THOSE ACHIEVED WITH USE OF TWO TIBIAL TUNNELS. POSTEROLATERAL BUNDLES HAD MORE TEARS AND POORER SYNOVIAL COVERAGE THAN ANTEROMEDIAL BUNDLES ON SECOND-LOOK ARTHROSCOPY. HOWEVER, CLINICAL OUTCOMES AFTER DOUBLE-BUNDLE ACL RECONSTRUCTION ARE NOT SIGNIFICANTLY CORRELATED WITH BUNDLE INTEGRITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331279 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention