BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFX SYM PDS+ UNI VIO 18IN 1 S/A CTX

    MDR report key: 12464939 · Received September 13, 2021

    Report

    Report Number
    2210968-2021-08366
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Date of Event
    August 19, 2021
    Report Date
    October 27, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031219366
    PMA / PMN Number
    K113004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 10/27/2021. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. 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 H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION EVALUATION WAS CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT AN EMPTY OPENED FOIL, A DETACHED NEEDLE, AND A SUTURE PIECE OF PRODUCT CODE SXPP1A400 WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE DETACHED NEEDLE, THE SWAGE, AND THE ATTACHMENT AREA WAS NOTED TO BE AS EXPECTED. THE BARREL HOLE OF THE DETACHED NEEDLE WAS EXAMINED UNDER MAGNIFICATION, AND NO SUTURE REMNANT WAS NOTED. THE SUTURE PIECE WAS EXAMINED, AND CORRECT INSERTION MARKS WERE OBSERVED; HOWEVER, THE FORCE USED TO DETACH THE NEEDLE FROM THE SUTURE COULD NOT BE DETERMINED. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE REPORTED COMPLAINT. TRADE NAME - IRGACARE® ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. ¿ STRENGTH ¿ = 2360 G/M.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. 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 NUMBER QEMBUC AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. (B)(4). 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. NOTE: EVENTS REPORTED IN 2210968-2021-08367. TRADE NAME - IRGACARE®, ACTIVE INGREDIENT(S) ¿ TRICLOSAN, DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL, STRENGTH ¿ = 2360 ¿G/M.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LOWER LIMB ARTHROPLASTY ON (B)(6) 2021 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD PULLED OFF WHEN CLOSING THE DEEP PLANE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361983 SFX SYM PDS+ UNI VIO 18IN 1 S/A CTX SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. SXPP1A400 QEMBUC 10705031219366

    Patients

    Seq Age Sex Outcome Treatment
    1