BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDSII VIO 18IN USP5-0

    MDR report key: 10747740 · Received October 28, 2020

    Report

    Report Number
    2210968-2020-08368
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 12, 2020
    Report Date
    October 12, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 11/24/2020. ADDITIONAL H6 INVESTIGATION FINDINGS: LIGHT SWAGE, PROCEDURE RELATED PHOTO REVIEW. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH PLK995, W9101H AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL H3 INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE SUTURE BROKE IN THE SWAGE NEEDLE. TWO PICTURES WERE RECEIVED FOR ANALYSIS.UPON TO VISUAL INSPECTION OF THE PICTURES, TWO LABELED WINDING FORMER, TWO DETACHED NEEDLES AND TWO SUTURES PIECE WITH THE ENDS WAVY OF PRODUCT CODE W9101, LOT PLK995 COULD BE OBSERVED. 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 ON WHAT CAUSED THE SUTURES BROKE SINCE DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONAL H3 INVESTIGATION SUMMARY: AN EMPTY WINDING FORMER, A PAPER LID, A DETACHED NEEDLE AND A DISPENSED SUTURE OF PRODUCT CODE W9101, LOT # PLK995 WERE RETURNED FOR ANALYSIS.DURING THE VISUAL INSPECTION OF DETACHED NEEDLE, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED AND NO SUTURE REMNANT COULD BE OBSERVED AT THE BARREL HOLE, THE ENDS OF THE SUTURE WAS EXAMINED AND THERE ISN¿T ENOUGH IMPRESSION AT THE SWAGE END, RESULTING IN A NEEDLE PULL OFF DEFECT. THE PULL-OUT DEFECT HAS BEEN CORRELATED TO THE MANUFACTURING PROCESS. THIS DEFECT IS CAUSED WHEN DOES NOT TIGHTENS THE PRESS CORRECTLY AND THE SWAGE AREA BE WEAK ON THE NEEDLE/SUTURE. 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. 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PLK995, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RHINOPLASTY PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE IN THE SWAGE PART ON THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY BUT WITH A TEN MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212538 PDSII VIO 18IN USP5-0 SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. PLK995

    Patients

    Seq Age Sex Outcome Treatment
    1