BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFXSPI PDS+ UNI VIO 27IN 0 SA CT-1

    MDR report key: 24144082 · Received January 22, 2026

    Report

    Report Number
    2210968-2026-00796
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    December 26, 2025
    Report Date
    January 22, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031236110
    PMA / PMN Number
    K150670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: ¿ DID THIS ISSUE CONTRIBUTE TO ANY PATIENT ADVERSE EVENT? ¿ CURRENTLY NO. SURGEON SAID THE PATIENT WAS OKAY. ¿ WHAT IS CURRENT CONDITION OF THE PATIENT? ¿ SURGEON SAID THE PATIENT WAS OKAY. ¿ PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP OR LOC/BQ) ON DD MMM YYYY: ¿ DR (B)(6) 2025. ¿ PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN NOTES OR RMAO SECTIONS. ¿ COLLECTION REQUESTED AS PER IN ATTACHED EMAIL THREAD. ADDITIONAL H11: SFXSPI PDS+ UNI VIO 27IN 0 SA CT-1 - SXPP1B408 (LOT: 109B3H) (SXPP1B408): LOT/BATCH NUMBER: 109B3H LIST ANY J&J PRODUCTS THAT WERE UTILIZED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. WAS THERE ANY REPORTED PATIENT OR USER HARM? NO. WAS THERE A SIGNIFICANT DELAY? NO. IF AVAILABLE, PROVIDE THE PRODUCT ORDER NUMBER (PO). NIL. SFXSPI PDS+ UNI VIO 27IN 0 SA CT-1 - SXPP1B408 (LOT: 109B3H). IS THE ACTUAL DEVICE WITH THE ALLEGED PRODUCT QUALITY ISSUE BEING RETURNED FOR ANALYSIS? OR IS AN ALTERNATIVE DEVICE BEING RETURNED? PLEASE SPECIFY. YES, THE ACTUAL FAULTY DEVICE HAS BEEN SET ASIDE FOR COLLECTION.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). DATE SENT TO THE FDA: 3/12/2026. 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. H6: COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. ADDITIONAL INFORMATION: D9, H3, H6. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. H3: INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETH FOR EVALUATION. VISUAL INSPECTION REVEALED THAT ONE EMPTY FOIL PACKET, ONE DETACHED NEEDLE AND ONE SUTURE PIECE WERE RECEIVED FOR ANALYSIS. PRODUCT CODE: SXPP1B408. DURING THE VISUAL INSPECTION OF DETACHED NEEDLE, THE SWAGE AND ATTACHMENT AREA DID NOT MEET EXPECTATIONS. SINCE, THE HIT OF THE STAKE WAS HIGHER THAN USUAL. THE SUTURE PIECE WAS EXAMINED AND AN INCORRECT INSERTION MARK WAS OBSERVED IN ONE OF THE EXTREMES. THIS CONDITION LIKELY CAUSED THE SUTURE TO BE SEPARATED FROM THE NEEDLE. BASED ON THE INFORMATION CURRENTLY AVAILABLE, AN INCORRECT SWAGE DEFECT WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH THE ETHICON QUALITY SYSTEM. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. ADDITIONAL H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETH FOR EVALUATION. VISUAL INSPECTION REVEALED THAT ONE NEEDLE SUTURE PIECE WAS RECEIVED FOR ANALYSIS. PRODUCT CODE: SXPP1B408. UPON VISUAL INSPECTION OF THE RETURNED SAMPLE, THE SWAGE AND ATTACHMENT AREA APPEARED AS EXPECTED. NO EVIDENCE OF SUTURE PULL-OFF OR NEEDLE DETACHMENT WAS OBSERVED. THE SUTURE END APPEARS TO HAVE BEEN CUT, LIKELY BY A SURGICAL INSTRUMENT. ADDITIONALLY, CRIMPING MARKS AND BODY FLUID WERE IDENTIFIED ON THE SAMPLE. AS THE SUTURE IS ABSORBABLE AND THE DURATION OF EXPOSURE OF THE SUTURE IN THE ENVIRONMENT COULD NOT BE DETERMINED, THE FUNCTIONAL TEST COULD NOT BE PERFORMED. AS PART OF ETH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.

    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, DR WAS USING STRATAFIX (SXPP1B408) TO CLOSE THE UTERUS DURING A C-SECTION CASE, BUT AS SHE WAS SUTURING, THE SUTURE DETACHED FROM THE NEEDLE (AT THE SWAGE). THE CIRCULATING NURSE OPENED A NEW STRAND AND THAT STRAND WAS OK (DID NOT DETACH LIKE THE FIRST STRAND) - DR USED THE SECOND STRAND TO CONTINUE CLOSING THE REMAINING OF THE UTERINE INCISION. AFTERWARDS, DUE TO CONCERNS FOR PATIENT SAFETY, SHE REINFORCED THE CLOSURE WITH VICRYL KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205579 SFXSPI PDS+ UNI VIO 27IN 0 SA CT-1 SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. 109B3H 10705031236110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown