BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL+ VIO 27IN 3-0 S/A SH

    MDR report key: 23184473 · Received September 30, 2025

    Report

    Report Number
    2210968-2025-11210
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    September 1, 2025
    Report Date
    December 4, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031046368
    PMA / PMN Number
    K050845
    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). 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: H6, D9, H3. H3 INVESTIGATION SUMMARY: A FAILED SUTURE NEEDLE, LABELED AS (B)(4), WAS SUBMITTED TO HERRERA, STAFFORD AND ASSOCIATES, LLC (HSA) FOR FRACTOGRAPHIC EVALUATION ON SEPTEMBER 25, 2025. THE COMPONENT WAS IDENTIFIED AS PRODUCT CODE MCP316H. IT WAS REQUESTED THAT HSA ASSESS THE FRACTURE MODE OF THE FAILURE. ACCORDING TO THE INFORMATION, IT WAS REPORTED BREAKAGE NEEDLE. THE PRODUCT RECEIVED FOR ANALYSIS WAS MCP316H. VISUAL INSPECTION AND METALLURGICAL ANALYSIS WERE PERFORMED ON THE RETURNED PRODUCT. A FRACTURE WAS OBSERVED IN THE BODY OF THE NEEDLE. THE NEEDLE WAS RECEIVED IN TWO PIECES, ONLY ONE OF THE MATING FRACTURE SURFACES WAS EXAMINED FOR THIS EVALUATION. A SCANNING ELECTRON MICROSCOPE (SEM) WAS USED TO EXAMINE THE FRACTURE SURFACES AND SURROUNDING AREA OF THE NEEDLE. THE FRACTURE SURFACES WERE EXAMINED IN MULTIPLE LOCATIONS TO DETERMINE THE FRACTURE MODE. THE EVALUATION OF (B)(4) REVEALED THE FRACTURE WAS COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE FRACTURE MODE. A CUP-AND-CONE SHAPED FRACTURE AND MACROSCOPIC PLASTIC DEFORMATION OBSERVED COINCIDENTAL TO THE FRACTURE PROVIDE ADDITIONAL EVIDENCE THAT THE FAILURE WAS INDUCED BY MECHANICAL DEFORMATION LEADING TO DUCTILE OVERLOAD. THIS WAS A DUCTILE FRACTURE. CORRECTED DATA: D4 UDI.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: * PLEASE CONFIRM IF THE NEEDLE AND SUTURE OF THE SAME DEVICE BROKE DURING THIS PROCEDURE. --ONLY THE NEEDLE BROKE DURING THIS PROCEDURE * DID ANY NEEDLE PIECE FELL INSIDE OF THE PATIENT ? WAS IT RETRIEVED DURING THE SAME PROCEDURE. IF YES HOW WAS IT RETRIEVED? --NO * WERE THERE ANY PATIENT CONSEQUENCES? --NO

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, DOCTOR USED SUTURE FOR SUTURING. DURING USE, IT WAS FOUND THAT THE SUTURE AND NEEDLE WERE BROKEN. THE DOCTOR REPLACED THE SUTURE FOR SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672855 MCRYL+ VIO 27IN 3-0 S/A SH SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. 10791E 10705031046368

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown