BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 23830046 · Received December 17, 2025

    Report

    Report Number
    2210968-2025-14162
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    October 13, 2025
    Report Date
    December 17, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H3 PHOTO INVESTIGATION SUMMARY: THIS IS AN ANALYSIS OF A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTO SHOWS THE WEARER HOLDING SEVERAL SUTURES OUT OF HIS PACKAGE, BETWEEN THE SUTURES IS SEEN AN ORANGE THREAD. BASED ON THE PHOTO REVIEW, THE EVENT REPORTED IS 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. 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. 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: * WERE THERE ANY PATIENT CONSEQUENCES? --NO. * PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN NOTES OR RMAO SECTIONS. --NO DEVICE CAN BE RETURNED. WHERE WAS THE FOREIGN MATERIAL FOUND? (INSIDE THE STERILE BARRIER OR OUTSIDE OF THE STERILE BARRIER?). --OUTSIDE OF THE STERILE BARRIER. PLEASE DESCRIBE THE TYPE OF FOREIGN MATTER THAT WAS OBSERVED. WHAT WAS THE FOREIGN MATTER¿S APPEARANCE? WHAT WAS THE TEXTURE? --SIMILAR TO DUST. ARE THERE ANY PHOTOS OF THE FOREIGN MATTER AVAILABLE? --NO. IS IT POSSIBLE THAT THE FOREIGN MATERIAL FELL INTO PACKAGING UPON OPENING OF DEVICE? --UNK. WAS THE PRODUCT SEAL ON THE FOIL STILL INTACT WHEN THE PACKAGE WAS OPENED? --YES. PLEASE DESCRIBE THE TYPE OF FOREIGN MATTER THAT WAS OBSERVED. WHAT WAS THE FOREIGN MATTER¿S APPEARANCE? ¿ WHAT WAS THE TEXTURE? ¿ ARE THERE ANY PHOTOS OF THE FOREIGN MATTER AVAILABLE? --PLEASE REFER TO ATTACHED PHOTO. WAS THE PRODUCT SEAL ON THE FOIL STILL INTACT WHEN THE PACKAGE WAS OPENED? --YES. IS IT POSSIBLE THAT THE FOREIGN MATERIAL FELL INTO PACKAGING UPON OPENING OF DEVICE? WHERE WAS THE FOREIGN MATERIAL FOUND? (INSIDE THE STERILE BARRIER OR OUTSIDE OF THE STERILE BARRIER?). --PLEASE REFER TO THE EVENT DESCRIPTION, OTHER INFORMATION REQUESTED IS UNKNOWN. THE MANUFACTURING RECORDS COULD NOT BE REVIEWED AS THE BATCH/LOT NUMBER IS UNKNOWN. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    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, WHEN PREPARING SUTURE BEFORE SURGERY, UPON OPENING THE PACKAGING, IMPURITIES WERE FOUND INSIDE THE SUTURE PACKAGE, AND SOME OF THE SUTURES HAD ABNORMAL COLORS. DISCARDED AND REPLACED THE SUTURE TO CONTINUE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186462 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown