BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFXSPI MCL+ UNI UD 18IN 4-0 SA PS-2 PMP

    MDR report key: 22184169 · Received June 11, 2025

    Report

    Report Number
    2210968-2025-06606
    Event Type
    Malfunction
    Date Received
    June 11, 2025
    Date of Event
    January 1, 2025
    Report Date
    July 11, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031236707
    PMA / PMN Number
    N12159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6 COMPONENT CODE: G07002 - DEVICE EVALUATION PENDING. 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. THE DEVICE UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: UNFORTUNATELY, WE DO NOT HAVE A LOT #. TRACKING #S: (B)(4). JLH IS GIVING FOLLOW UP ANSWERS. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THE MANUFACTURING RECORDS COULD NOT BE REVIEWED AS THE BATCH/LOT NUMBER IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 7/8/2025. 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: H3, H6. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE LABELED WINDING FORMER WITH A NEEDLE SUTURE COMBINATION WERE RECEIVED FOR ANALYSIS. DURING VISUAL INSPECTION OF THE SAMPLE, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. MARKS ON THE BODY NEEDLE APPEAR TO BE BY USE OF SURGICAL INSTRUMENT COULD BE OBSERVED. THE SUTURE WAS EXAMINED, NOT BODY FLUIDS ALONG OF STRAND WERE FOUND. IN ADDITION, IT WAS OBSERVED THAT THE WELD OF FIRST LOOP WAS DETACHED. HOWEVER, THE LOOP POSSIBLY FAILURE DUE TO EXCESSIVE FORCE APPLIED. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOTS-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS ON WHAT CAUSED THE REPORTED COMPLAINT. 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). CORRECTED INFORMATION: H3 INVESTIGATION SUMMARY. ADDITIONAL INFORMATION: D 4. PRIMARY UDI NUMBER. CORRECTED INVESTIGATION SUMMARY ==> THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE LABELED WINDING FORMER WITH A NEEDLE SUTURE COMBINATION WERE RECEIVED FOR ANALYSIS. THE PRODUCT CODE IS SXMP1B118. DURING VISUAL INSPECTION OF THE SAMPLE, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. MARKS ON THE BODY NEEDLE APPEAR TO BE BY USE OF SURGICAL INSTRUMENT COULD BE OBSERVED. THE SUTURE WAS EXAMINED, NOT BODY FLUIDS ALONG OF STRAND WERE FOUND. IN ADDITION, IT WAS OBSERVED THAT THE WELD OF FIRST LOOP WAS DETACHED. HOWEVER, THE LOOP POSSIBLY FAILURE DUE TO EXCESSIVE FORCE APPLIED. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS ON WHAT CAUSED THE REPORTED COMPLAINT. THE INSTRUCTIONS FOR USE DO CONTAIN THE FOLLOWING CAUTION: FOR THE DEVICE TO FUNCTION PROPERLY, THE STRATAFIX¿ SPIRAL PDS¿ PLUS DEVICE MUST FIRST BE ANCHORED IN ROBUST TISSUE USING THE FIXATION LOOP. THEN SUBSEQUENTLY ENGAGE THE BARBS INTO THE TISSUE IN A STANDARD CLOSURE PATTERN. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING TWO CASES, THE ITEM BROKE WHILE SUTURING. CASES WERE COMPLETED WITH LIKE PRODUCT. NO PATIENT HARM WAS REPORTED. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90309 SFXSPI MCL+ UNI UD 18IN 4-0 SA PS-2 PMP SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON INC. 10705031236707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown