BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL VIO 27IN 2-0 S/A UR-6

    MDR report key: 23707760 · Received December 3, 2025

    Report

    Report Number
    2210968-2025-13564
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    October 12, 2025
    Report Date
    December 3, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031059481
    PMA / PMN Number
    K960653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: B 5. EVENT DESCRIPTION. CORRECTED B 5. EVENT DESCRIPTION: IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. TOTAL THREE PRODUCTS HAD THE NEEDLE PULL OFF ISSUE OCCUR. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHEN WERE THE NEEDLES DETACHED/PULLED OFF FROM THE SUTURES (IN THE PACKAGE, DURING REMOVAL FROM PACKAGE, DURING HANDLING PRIOR TO USE ON PATIENT OR DURING USE ON THE PATIENT)? PLEASE SPECIFY. H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETH FOR EVALUATION. VISUAL INSPECTION REVELATED THAT ONE LABELED WINDING FORMER WHITE ONE DETACHED NEEDLE THAT PERTAINS TO PRODUCT CODE Y605H. DURING THE VISUAL INSPECTION OF THE RETURNED NEEDLE, THE SWAGE AND ATTACHMENT AREA WAS NOTED TO BE AS EXPECTED. THE BARREL HOLE OF THE NEEDLE WAS EXAMINED UNDER MAGNIFICATION, AND NO SUTURE REMNANT WAS OBSERVED. THE SUTURE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE REPORTED COMPLAINT. AS PART OF ETH QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. TOTAL THREE PRODUCTS HAD THE NEEDLE PULL OFF ISSUE OCCUR. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. TOTAL THREE PRODUCTS HAD THE NEEDLE PULL OFF ISSUE OCCUR. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2787434 MCRYL VIO 27IN 2-0 S/A UR-6 SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. 1032HB 10705031059481

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown