BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STFX SYM PDS+ UNI VIO 24IN 1 S/A OS-8

    MDR report key: 12609580 · Received October 11, 2021

    Report

    Report Number
    2210968-2021-09488
    Event Type
    Malfunction
    Date Received
    October 11, 2021
    Date of Event
    September 15, 2021
    Report Date
    November 29, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031245266
    PMA / PMN Number
    K141776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 11/29/2021. H3 INVESTIGATIONAL NARRATIVE: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT ONE SAMPLE, OF PRODUCT CODE SXPP1A205, WAS RECEIVED TO ETHICON INC FOR EVALUATION. AFTER INVESTIGATION OF THE SAMPLE, SHORT INSERTION WAS OBSERVED IN THE STRAND. THE VISUAL INSPECTION CONCLUDED THAT THE COMBINATION OF THE NEEDLE/SUTURE WAS FOUND DETACHED SINCE THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIREMENT. THE PULL-OUT HAS BEEN CORRELATED TO THE MANUFACTURING PROCESS. THIS DEFECT IS CAUSED BECAUSE THE SUTURE WAS NOT PROPERLY INSERTED INSIDE OF THE NEEDLE BARREL HOLE RESULTING IN A PULL-OUT DEFECT. BASED ON THE INFORMATION CURRENTLY AVAILABLE, THE PULL-OUT WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH ETHICON INC¿S QUALITY SYSTEM. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. 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. 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: PLEASE CLARIFY IF THE SUTURE BROKE INTO SEPARATE PIECES IN THE SWAGE POINT OR IF THE ENTIRE SUTURE SEPARATED FROM THE NEEDLE. THE ENTIRE SUTURE SEPARATED FROM THE NEEDLE. WERE THERE ANY PATIENT CONSEQUENCES? NO. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ¿ TRADE NAME - IRGACARE®, ¿ ACTIVE INGREDIENT(S) ¿ TRICLOSAN, ¿ DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL, ¿ STRENGTH ¿ = 2360 UG/M.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE BARBED SUTURE SEPARATED FROM THE NEEDLE AT THE SWAGE PART. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504478 STFX SYM PDS+ UNI VIO 24IN 1 S/A OS-8 SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. SXPP1A205 QPMBUB 10705031245266

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown