BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7824131 · Received August 28, 2018

    Report

    Report Number
    2210968-2018-75487
    Event Type
    Injury
    Date Received
    August 28, 2018
    Report Date
    August 16, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? . DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: INDIAN J SURG (DECEMBER 2015) 77 (SUPPL 3):S936¿S940; DOI 10.1007/S12262-014-1068-8 - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : DIFFERENT SUTURES IN THE SURGICAL TREATMENT OF ACUTE CLOSED ACHILLES TENDON RUPTURE" AUTHOR: YUNHAN JI , XIN MA , XU WANG , JIAZHANG HUANG , CHAO ZHANG , LI CHEN CITATION: INDIAN J SURG (DECEMBER 2015) 77 (SUPPL 3):S936¿S940; DOI 10.1007/S12262-014-1068-8. THE AIM WAS TO COMPARE THE POSTOPERATIVE EFFICACY OF THE PDS II AND ETHIBOND W4843 SUTURES IN FRESH, CLOSED ACHILLES TENDON RUPTURE. FROM JAN2006 TO DEC2010, 128 PATIENTS WITH CLOSED ACHILLES TENDON RUPTURE UNDERWENT REPAIR WITH BUNNELL METHOD AND WERE RANDOMLY DIVIDED INTO TWO GROUPS BASED ON SUTURE USED: PDS II SUTURE (GROUP A; N=32 MALE AND N=9 FEMALE; AGE OF 45.3±8.3 YEARS) AND ETHIBOND W4843 (GROUP B; N=63 MALE AND N=24 FEMALE; AGE OF 44.7±7.1 YEARS). IN THE PROCEDURE, THE SUTURE WAS THREADED WITH A DOUBLE RECTO NEEDLE AT 4CM AWAY FROM THE STUMP, USING BUNNEL METHOD. IN CASES WHERE THE STRENGTH IS NOT ENOUGH, A 3.0 VICRYL SUTURE CAN BE USED TO STRENGTHEN THE SUTURE LINE AND FOR THE APONEUROSIS TO BECOME SMOOTH. IN GROUP A, COMPLICATIONS INCLUDED RE-RUPTURE 5 MONTHS POSTOPERATIVELY (N=1), SURFACE INFECTION (N=5) THAT HEALED AFTER 14-36 DAYS, WOUND EXUDATE (N=1) WHICH RECOVERED AFTER TWO DEBRIDEMENT, ACHILLES TENDON ADHESION (N=7) AND MINIMAL DORSIFLEXION AT 5° TO 10° (N=12). IN GROUP B, COMPLICATIONS INCLUDED SURFACE INFECTION (N=7) THAT HEALED AFTER 16-25 DAYS, ACHILLES TENDON ADHESION (N=13) AND FEWER ANKLE ACTIVITIES OR MINIMAL FOOT DORSIFLEXION AT 5° TO 10° (N=19). THE ETHIBOND W4843 POLYBUTYLATE AND PDS II SUTURES HAVE INSIGNIFICANT DIFFERENCE IN PERFORMANCE WITH REGARD TO INCISION INFECTION, RE-RUPTURE RATE, TENDON ADHESION, AND ANKLE-MOVEMENT LIMITATION. THE ETHIBOND SUTURE HAS CERTAIN ADVANTAGES, SO IT CAN BE USED AS AN IDEAL SURGICAL MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663636 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention