BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHLN BLK 12IN 10-0 D/A TG140-6

    MDR report key: 21773241 · Received April 4, 2025

    Report

    Report Number
    2210968-2025-03562
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    March 10, 2025
    Report Date
    May 5, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    UDI-DI
    10705031202528
    PMA / PMN Number
    K946173
    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: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE FOAM PARK WITH TWO NEEDLE SUTURE PIECES INSIDE THE OPEN OVERWRAP PACKET WAS RECEIVED FOR ANALYSIS. THE PRODUCT CODE W1770 IS DOUBLE ARMED. DURING THE VISUAL INSPECTION OF THE RETURNED SAMPLE, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURE PIECES WERE EXAMINED AND WAVY SUTURE WAS OBSERVED IN ONE SUTURE PIECES. THE ENDS OF THE SUTURE PIECES WERE NOTED TO BE CUT PROBABLY BY A SURGICAL INSTRUMENT. A FUNCTIONAL TEST WAS PERFORMED IN A NEEDLE SUTURE PIECE USING INSTRON EQUIPMENT AND THE TENSILE FORCE WAS ABOVE THE MINIMUM REQUIREMENTS. PER THE CONDITION OF THE RETURNED SAMPLE, NO CONCLUSION COULD BE REACH ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: AS WITH ANY DEVICE, CARE SHOULD BE TAKEN TO AVOID DAMAGE TO THE STRAND WHEN HANDLING. AVOID THE CRUSHING OR CRIMPING ACTION OF THE SURGICAL INSTRUMENTS, SUCH AS NEEDLE HOLDERS AND FORCEPS. AS PART OF ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS.

    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. H6 COMPONENT CODE: G07002 PENDING DEVICE EVALUATION. THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2323453 ETHLN BLK 12IN 10-0 D/A TG140-6 SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. UABBUB 10705031202528

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown