BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL VIO 36IN 0 S/A CT-1

    MDR report key: 19817248 · Received July 24, 2024

    Report

    Report Number
    2210968-2024-07569
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    January 1, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031058910
    PMA / PMN Number
    K960653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING RESPONSE WAS OBTAINED: PLEASE CONFIRM THE NUMBER OF SUTURES USED ON "THE INTERNAL BODY WALL LAYER" THAT WERE FOUND RIPPED (PER BUNNY). ONE SIMPLE CONTINUOUS SUTURE WAS PLACED IN LINEA ALBA / BODY WALL FOR EACH RABBIT WHICH BROKE / FAILED. OTHER SUTURES WHICH DID NOT FAIL WERE PLACED WITH 2-0 MONOCRYLE (SQ SIMPLE CONTINUOUS AND INTRADERMAL LAYERS) IS THIS DEVICE OR SAMPLES FROM THE SAME LOT AVAILABLE FOR ANALYSIS? BOTH OF THE LINEA ALBA / BODY WALL SUTURES WERE FROM THE SAME 0-0 MONOCRYLE BOX. WE DO HAVE THE BOX THAT BOTH SUTURES PACKS CAME FROM. PHOTO ANALYSIS SUMMARY: THIS IS AN ANALYSIS FOR A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTO SHOWS AN OPEN BOX WITH PRODUCT CODE Y346H. THE IMAGE IS NOT CLEAR TO DETERMINE THE FAILURE MODE OR THE REPORTED CONDITION. BASED ON THE PHOTO REVIEW, THE EVENT DESCRIBE IS NOT CONFIRMED, HOWEVER NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. BECAUSE THE DEVICE WAS NOT RETURNED OUR EVALUATION IS LIMITED. WE VALUE THE OPPORTUNITY TO FULLY ANALYZE THE DEVICE UPON ITS RETURN. AS PART OF ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. ATTEMPTS ARE BEING MADE TO RETRIEVE THE DEVICE. 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BUNNY UNDERWENT A SPAY PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. FOUR DAYS LATER THE INTERNAL BODY WALL LAYER SUTURE HAD RIPPED, BUT NOT THE OUTER SKIN LAYER. SURGEON HAD CONCERNS BECAUSE OF IT BEING THE INTERNAL BODY WALL LAYER THAT HAD BROKEN. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2303318 MCRYL VIO 36IN 0 S/A CT-1 SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. THMPDD 10705031058910

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown