BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22011243 · Received May 13, 2025

    Report

    Report Number
    2210968-2025-05263
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    April 7, 2025
    Report Date
    May 13, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 6/16/2025 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, 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: D9, H3, H6 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE WINDING FORMER WITH A DETACHED NEEDLE THAT PERTAINS TO THE PRODUCT SXMP1B111 WAS RECEIVED FOR ANALYSIS. DURING VISUAL INSPECTION OF THE NEEDLE. MARKS WERE NOTED AT THE EDGE OF THE SWAGE AREA. THE BARREL HOLE WAS EXAMINED, AND A SUTURE REMNANT WAS OBSERVED. BESIDES THAT, THE HOLE WAS CRUSHED. THE SUTURE WAS NOT RETURNED FOR EVALUATION. 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.

    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. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. IT WAS REPORTED ON THE ATTACHMENT IMG_4311.JPEG THAT THE "FREQUENCY OF THE PROBLEM IS RECURRING". DID THE REPORTED DEFICIENCY RECUR DURING THE SAME PROCEDURE? IF YES, HOW MANY DEVICES DEMONSTRATED THE REPORTED ALLEGED DEFICIENCY? IF THIS OCCURRED IN MULTIPLE PROCEDURES, PLEASE CONFIRM THE NUMBER OF PATIENTS AFFECTED BY THE ALLEGED DEFICIENCY. HAVE ANY OF THESE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? IF YES, PROVIDE THE RESPECTIVE REFERENCE NUMBER(S). PLEASE CREATE A NEW PC FILE FOR EACH PATIENT/EVENT. HOW MANY DEVICES DEMONSTRATED THE ALLEGED DEFICIENCY DURING EACH PROCEDURE? PLEASE CONFIRM, HOW MANY DEVICES ARE AVAILABLE TO BE RETURNED FOR PRODUCT ANALYSIS? PLEASE PROVIDE THE STATUS OF THE DEVICE(S) AS IT HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE HAS BEEN SHIPPED, PLEASE PROVIDE THE SHIPMENT TRACKING DETAILS. PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN SURGEON WENT TO USE THE SUTURE, THE THREAD POPPED OFF THE NEEDLE. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184135 SFXSPI MCL+ UNI UD 18IN 3-0 SA PS PMP SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON INC. 103LCD 10705031236660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown