BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFXSPI MCL+ UNI UD 18IN 3-0 SA PS PMP

    MDR report key: 22090263 · Received May 27, 2025

    Report

    Report Number
    2210968-2025-05894
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    January 1, 2025
    Report Date
    May 27, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031236660
    PMA / PMN Number
    K151200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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. 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. PLEASE PROVIDE AN ANSWER FOR EACH COMPLAINT: (B)(4) - WERE THERE ANY ADVERSE CONSEQUENCES ASSOCIATED WITH THE PATIENT? - PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS:

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, ON TWO OCCASIONS, WHEN ORTHO SURGEON WAS USING STRATAFIX SPIRAL MONOCRYL, THE LOOP BROKE OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330730 SFXSPI MCL+ UNI UD 18IN 3-0 SA PS PMP SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON INC. 100S6E 10705031236660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown