BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATAFIX

    MDR report key: 25032992 · Received April 29, 2026

    Report

    Report Number
    2210968-2026-04622
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 10, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ETHICON, INC.
    Product Code
    NEW
    UDI-DI
    10705031236295
    PMA / PMN Number
    K150670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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, 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. HOW MANY DEVICES DEMONSTRATED THE ALLEGED DEFICIENCY? PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN NOTES OR RMAO SECTIONS. PLEASE PROVIDE THE TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (E.G. NURSE, SURGEON, RISK MANAGER). ADDITIONAL H11: SFXSPI PDS+ UNI VIO 18IN 4-0 SA PS-2 PMP (SXPP1B113) : NOT APPLICABLE SFXSPI PDS+ UNI VIO 18IN 4-0 SA PS-2 PMP (SXPP1B113) : LOT CODE / LOT NUMBER: 1090T3 LIST OF OTHER J&J PRODUCTS (NON-CUSTOMER COMPLAINT PRODUCTS) USED IN THE CASE SURGERY. HAS THERE BEEN A PATIENT OR USER INJURY REPORT? NO ARE THERE ANY NOTICEABLE DELAYS? NO IF AVAILABLE, PROVIDE THE PRODUCT ORDER NUMBER (PO).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER'S STITCHES BROKE WHILE USING OUR PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42473 STRATAFIX SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON, INC. 1090T3 10705031236295

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown