BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE

    MDR report key: 7366459 · Received March 23, 2018

    Report

    Report Number
    2210968-2018-71634
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Report Date
    March 14, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. 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. THE INFORMATION IN THE ARTICLE INDICATES THAT TWO PATIENTS HAD SUTURES BROKEN AROUND THE SPERMATIC CORD. DID THE OTHER PATIENT (NOT THE ONE THAT WAS REOPERATED ON) ALSO HAVE VICRYL SUTURES PLACED OR SOME OTHER TYPE OF SUTURE? IF VICRYL SUTURE WAS USED, CAN YOU PROVIDE THE PRODUCT CODE AND LOT NUMBER INVOLVED? WAS THERE ANY SUTURE DEFICIENCY NOTED PRIOR TO / DURING/ POST OPERATIVELY? WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION REQUIRED FOR THE OTHER PATIENT? PLEASE PROVIDE PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE, PROCEDURE DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE ENTITLED: RECURRENCE MECHANISMS AFTER INGUINAL HERNIA REPAIR BY THE ONSTEP TECHNIQUE: A CASE SERIES AUTHOR(S): S. OBERG, K. ANDRESEN, D. HAUGE2, J. ROSENBERG CITATION: HERNIA (2016) 20:681¿685; DOI 10.1007/S10029-016-1496-4. THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE RECURRENCES AFTER ONSTEP OPERATION FOR INGUINAL HERNIAS, AND THUS SUGGEST METHODS TO IMPROVE THE TECHNIQUE. BETWEEN DEC 2011 AND APR 2015, 565 MALE PATIENTS, AGES 17 TO 19 YEARS, WITH 569 INGUINAL HERNIAS UNDERWENT ONSTEP REPAIR. THERE WERE A TOTAL OF 26 RECURRENCES, 18 OF THESE WAS NOTED ON THE FIRST HALF OF THE OBSERVATIONAL PERIOD, WHILE 8 WERE NOTED IN THE SECOND HALF. THE ONSTEP MESH (POLYSOFT MESH) IS MEDIALLY PLACED THROUGH AN OPENING IN FASCIA TRANSVERSALIS AND LATERALLY, IT IS SUTURED AROUND THE SPERMATIC CORD. AND IN ONE PATIENT, VICRYL SUTURES WERE UTILIZED AROUND THE SPERMATIC CORD. ONE OF THE PATIENTS HAD SUTURES BROKEN AROUND THE SPERMATIC CORD. THE MAIN REASONS FOR RECURRENCE MAY BE BROKEN SUTURES IN THE MESH LATERALLY OR A SUBOPTIMAL SIZE OF THE OPENING IN FASCIA TRANSVERSALIS MEDIALLY, ENABLING THE MESH TO DISPLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210849 VICRYL POLYGLACTIN 910 SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1