BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL UD 27IN 6-0 S/A TF MP

    MDR report key: 23820906 · Received December 16, 2025

    Report

    Report Number
    2210968-2025-14137
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 19, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031059177
    PMA / PMN Number
    K964072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHEN DID THE ALLEGED DEFICIENCY OCCUR (REMOVAL FROM PACKAGE / DURING HANDLING PRIOR TO USE ON PATIENT/ DURING PASSAGE THROUGH TISSUE / DURING TYING / POST-OP)? IF DIFFERENT, PLEASE EXPLAIN. RECEIVED INFORMATION AS FOLLOWING FROM SALES REP VIA PHONE TODAY. PLEASE REFER TO THE EVENT DESCRIPTION, OTHER INFORMATION REQUESTED IS UNKNOWN. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETH FOR EVALUATION. VISUAL INSPECTION REVELATED THAT ONE WINDING FORMER WITH A SUTURE, ONE NEEDLE AND ONE EMPTY OPENED FOIL WERE RECEIVED FOR ANALYSIS. PRODUCT CODE Y432H. UPON VISUAL ASSESSMENT OF THE WINDING FORMER, IT WAS NOTED THAT THE SUTURE WAS BROKEN IN SEVERAL PIECES SINCE THE PROCESS OF DEGRADATION BEGAN. WHICH CAUSED THE NEEDLE TO COME OUT FROM THE NEEDLE. THE FOIL WAS VISUALLY INSPECTED, AND EXCESSIVE WRINKLES AND HOLES IN THE CAVITY WERE OBSERVED. THE CONDITION OF THE PACKAGE IS INDICATIVE OF HANDLING AND STORAGE ISSUES THAT OCCURRED OUTSIDE OF ETHICON CONTROL. 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 LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN CLOSURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE SURGERY. THE NEEDLE DID NOT FALL INTO THE PATIENT. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744061 MCRYL UD 27IN 6-0 S/A TF MP SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. RHMKCP 10705031059177

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown