BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND* GRN 2 4 X 75CM V40

    MDR report key: 7401177 · Received April 5, 2018

    Report

    Report Number
    2210968-2018-71955
    Event Type
    Injury
    Date Received
    April 5, 2018
    Report Date
    March 19, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. CITATION: INDIAN J SURG. 2015; 77(3): S936 S940. DOI: 10.1007/S12262-014-1068-8. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE TITLE: DIFFERENT SUTURES IN THE SURGICAL TREATMENT OF ACUTE CLOSED ACHILLES TENDON RUPTURE. AUTHORS: YUNHAN JI, XIN MA, XU WANG, JIAZHANG HUANG, CHAO ZHANG, LI CHEN CITATION: INDIAN J SURG. 2015; 77(3): S936 S940. DOI: 10.1007/S12262-014-1068-8. THE AIM OF THIS STUDY WAS TO COMPARE THE POST-OPERATIVE EFFICACY OF THE PDS II AND ETHIBOND W4843 SUTURES IN FRESH, CLOSED ACHILLES TENDON RUPTURE. A TOTAL OF 128 PATIENTS WITH FRESH ACHILLES TENDON RUPTURE UNDERWENT SURGICAL OPERATION. OF WHICH, 41 PATIENTS (32 MALE AND 9 FEMALE; AGE RANGE: 16 TO 73 YEARS OLD) WERE RANDOMIZED UNDER GROUP A (PDS II SUTURES) AND 87 PATIENTS (63 MALE AND 24 FEMALE; AGE RANGE: 19 TO 65 YEARS OLD) WERE RANDOMIZED UNDER GROUP B (ETHIBOND W4843 SUTURES). DURING THE SURGICAL PROCEDURE, GROUP A USED PDS II SUTURE WHEREAS GROUP B USED ETHIBOND W4843 SUTURE. THE SUTURE WAS THREADED WITH A DOUBLE RECTO NEEDLE AT 4 CM AWAY FROM THE STUMP, USING THE BUNNELL METHOD. THE STUMP WAS STRETCHED TO A SUITABLE INVOLUTION, AND THE LINE KNOT WAS LEFT INSIDE, WITH MODERATE TENSION APPLIED ON THE ACHILLES TENDON. IN CASES WHERE THE STRENGTH IS NOT ENOUGH, A VICRYL 3-0 SUTURE CAN BE USED TO STRENGTHEN THE SUTURE LINE AND FOR THE APONEUROSIS TO BECOME SMOOTH. IN GROUP A, REPORTED COMPLICATIONS INCLUDED INCISION INFECTION (N-6) IN WHICH 1 PATIENT REPORTED THAT THE WOUND PRODUCED EXUDATE BUT RECOVERED AFTER DEBRIDEMENT WAS DONE TWICE AND ACHILLES TENDON ADHESIONS (N-7). IN GROUP B, REPORTED COMPLICATIONS INCLUDED INCISION INFECTION (N-11) AND ACHILLES TENDON ADHESIONS (N-13). IT WAS REPORTED THAT THE RESULT OF OUR COMPARISON CONFIRMED THAT ALTHOUGH GROUP B HAS SIMILAR INTRAOPERATIVE COMPLICATIONS WITH GROUP A, IT HAS LESS POST-OPERATIVE COMPLICATIONS AND PROVIDES A NUMBER OF ADVANTAGES IN FUNCTION IMPROVEMENT AND PAIN CONTROL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244128 ETHIBOND* GRN 2 4 X 75CM V40 SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention