BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21252120 · Received January 28, 2025

    Report

    Report Number
    2210968-2025-01012
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    January 1, 2025
    Report Date
    January 28, 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). DATE SENT TO THE FDA: 1/28/2025. H6 COMPONENT CODE: G07002 - NO DEVICE PROBLEM FOUND. 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. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: * CAN YOU IDENTIFY THE LOT NUMBER OF THE PRODUCT THAT WAS USED? * WHAT IS THE PROCEDURE NAME AND DATE? * PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF THE EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP) NO FURTHER INFORMATION AVAILABLE. PRODUCT SHIPPED IN. PROCEDURE WAS ORTHOPEDIC. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE USED NEEDLE- SUTURE PIECE OUTSIDE ITS PACKAGING WAS RECEIVED FOR ANALYSIS. DURING VISUAL INSPECTION OF THE RETURNED SAMPLE, THE SWAGE AND ATTACHMENT AREA WERE OBSERVED AS EXPECTED; HOWEVER, MARKS THAT APPEAR TO BE CAUSED BY A SURGICAL INSTRUMENT WERE OBSERVED ON THE BODY NEEDLE. ALSO, A LITTLE SUTURE PIECE WAS NOTED TO BE STILL ATTACHED TO THE BARREL HOLE. OVERALL, NO NEEDLE PULL-OFF WAS OBSERVED. THE FUNCTIONAL TEST WAS NOT POSSIBLE TO PERFORM ACCORDING TO SUTURE. LENGTH. THE SUTURE WAS EXAMINED, SPLIT SUTURE AND THE EXTREME WAS NOTED TO BE CUT PROBABLY CAUSED BY A SURGICAL INSTRUMENT. IN ADDITION, BODY FLUIDS WERE NOTED ALONG THE STRAND. THE OTHER SECTION OF THE SUTURE WAS NOT RETURNED FOR ANALYSIS. AS PART OF ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE CAME OFF SUTURE. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2376743 SFXSPI MCL+ UNI UD 18IN 3-0 SA PS PMP SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON INC. 10705031236660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown