BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL SUTURE 36"(90CM) 0 VIO

    MDR report key: 23289288 · Received October 15, 2025

    Report

    Report Number
    2210968-2025-11743
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    January 1, 2025
    Report Date
    October 14, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031060005
    PMA / PMN Number
    K960653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 11/3/2025 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. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND ADDITIONAL INFORMATION: D9, H3, H6 H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE EMPTY BOX AND SIXTEEN UNOPENED SAMPLES WERE RECEIVED FOR ANALYSIS. FOLLOWING THE SAMPLING PLAN, A VISUAL INSPECTION WAS CONDUCTED ON THIRTEEN SAMPLES. THE PACKETS WERE EXAMINED FOR VISUAL DEFECTS: APPEARANCE, COLOR PACKAGE, WRINKLES IN THE SEAL AREA, CONTINUOUS SEALS, SEAL MARGINS, OVER-SEALING, DAMAGE (TORN, PUNCTURED) AND NONE WAS OBSERVED. THE PACKETS WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED AS EXPECTED. HOWEVER, ON ONE SAMPLE IT WAS NOTED THAT THE NEEDLE WAS DETACHED FROM THE SUTURE. IN FURTHER INVESTIGATION, A SHORT INSERTION WAS OBSERVED AT THE END OF THE SUTURE. VISUAL INSPECTION CONCLUDED THAT THE NEEDLE AND SUTURE WERE DETACHED, AS THE INSERTION END OF THE SUTURE DID NOT MEET THE SPECIFIED REQUIREMENTS. DURING THE VISUAL INSPECTION, THE SUTURES WERE CORRECTLY PLACED ON THE WINDING FORMER. SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND AND NO ANOMALIES OR DAMAGE ON THE SURFACE OF THE SUTURE COULD BE OBSERVED. THE FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT AND THE TENSILE FORCE WAS ABOVE THE MINIMUM REQUIREMENTS. BASED ON THE INFORMATION CURRENTLY AVAILABLE, SHORT INSERTION ISSUE WAS IDENTIFIED AS PULL OUT DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH THE ETHICON QUALITY SYSTEM. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) DATE SENT TO THE FDA: 10/14/2025. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED THE FOLLOWING WAS OBTAINED: CAN YOU IDENTIFY THE LOT NUMBER AND PRODUCT CODE OF THE PRODUCT USED? LOT # REMMZC AND Y987 WHAT WAS THE APPEARANCE OF THE SUTURE AFTER THE WOUND DEHISCENCE THAT OCCURRED ON THE ANIMAL? PLEASE EXPLAIN. UNKNOWN EXACT STATE OF THE SUTURE AS PATIENTS PRESENTED TO THE ER AND NOT HERE AT THE CLINIC. I CAN PROVIDE YOU WITH PETS RECORDS IF NEEDED DID THE SUTURE BREAK POST-OP? YES DID THE SUTURE PULL OUT OF THE TISSUE? IT WAS NOT 100% CLEAR FROM THE SURGERY REPORTS BUT IT DOES SEEM LIKE IT COULD HAVE PULLED OUT OF THE TISSUES. IS THIS DEVICE OR SAMPLES FROM THE SAME LOT AVAILABLE FOR ANALYSIS? YES IF YES, TO WHOM SHOULD THE SHIPPER KIT BE SENT? (PLEASE REFER TO THE ATTACHED EMAIL) PLEASE PROVIDE THE TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP DR. (PLEASE REFER TO THE ATTACHED EMAIL), MEDICAL LEAD PLEASE PROVIDE THE STATUS OF THE DEVICE(S) AS IT HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE HAS BEEN SHIPPED, PLEASE PROVIDE THE SHIPMENT TRACKING DETAILS. IHAVE IT READING FOR SHIPPING. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON REPORTED THAT IN ALL THREE CASES, THE PATIENTS EXPERIENCED BODY WALL DEHISCENCE WITHIN TWO DAYS POST-OPERATION, WITH ONE PATIENT EXPERIENCING WOUND RUPTURE AT 11 DAYS POST-OP AND ANOTHER AT 15 DAYS POST-OP. ALL THREE PATIENTS REQUIRED EMERGENCY CARE. THE DEVICES ARE AVAILABLE FOR RETURN. THE EVENT IS BEING REPORTED FOR DOCUMENTATION PURPOSES. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2597263 MONOCRYL SUTURE 36"(90CM) 0 VIO SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. REMMZC 10705031060005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown