BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS II POLYDIOXANONE SUTURE

    MDR report key: 8137916 · Received December 6, 2018

    Report

    Report Number
    2210968-2018-77565
    Event Type
    Malfunction
    Date Received
    December 6, 2018
    Date of Event
    November 9, 2018
    Report Date
    November 12, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 1/21/2019. EVALUATION: ONE COMPLAINT SAMPLE FOIL WITH SBF FOLDER SUTURE AND NEEDLE IN SEPARATED CONDITION WAS RECEIVED. THE COMPLAINT SAMPLE WAS RECEIVED IN OPEN CONDITION SO FURTHER INVESTIGATION ON COMPLAINT SAMPLE CANNOT BE PERFORMED. THE FOIL PACK WAS INSPECTED UNDER MAGNIFICATION FOR ANY DAMAGE AND SHOWED A MULTITUDE OF WRINKLES OVER THE WHOLE FOIL ALONG WITH SEVERAL PINHOLES AT THE TOP LABEL SIDE AS WELL AS ON BOTTOM CAVITY SIDE OF THE PACKS. THE RETURNED NEEDLE WAS INSPECTED WITH MAGNIFICATION AND NO ANY DEFECT WAS OBSERVED. FIVE RETAIN SAMPLES OF INCIDENT CODES AND LOT NUMBER WERE RETRIEVED FOR ANALYSIS. THE PRIMARY PACKS OF RETAIN SAMPLES WERE VISUALLY INSPECTED FOR ATTRIBUTE DEFECTS, BUT NO SUCH DEFECTS WERE OBSERVED. THE PRIMARY PACKS WERE OPENED, AND SUTURES AND NEEDLES WERE FOUND INTACT. THE SUTURES WERE PHYSICALLY INSPECTED FOR ANY ATTRIBUTE DEFECTS, BUT NO SUCH DEFECTS WERE OBSERVED. THE NEEDLES WERE INSPECTED FOR ANY ATTRIBUTE DEFECTS, BUT NO SUCH DEFECTS WERE OBSERVED. THE RETAIN SAMPLES WERE TESTED FOR KNOT PULL TENSILE STRENGTH AND FOUND TO MEET THE SPECIFICATION. AS A PART OF FURTHER INVESTIGATION BATCH MANUFACTURING RECORD WAS REVIEWED. THE BATCH MANUFACTURING RECORD WAS REVIEWED FOR ANY PROCESS DEVIATION, BUT NO DEVIATION WAS OBSERVED. FINISHED GOOD RECORD WAS REVIEWED FOR TENSILE STRENGTH VALUE AND NEEDLE PULL-OFF VALUE AT RELEASE AND FOUND TO MEET THE SPECIFICATION. FROM THE ABOVE ANALYSIS, IT IS EVIDENT THAT THERE WAS NO ISSUE RELATED TO THE SUTURE QUALITY AND PROCESSING OF THIS INCIDENT LOT. AS THE COMPLAINT IS RELATED TO SUTURE BREAKAGE, KNOT PULL TENSILE STRENGTH TEST IS APPLICABLE & MEASURABLE PARAMETER. KNOT PULL TENSILE STRENGTH TEST WAS PERFORMED OVER FIVE RETAIN SAMPLES TO CHECK THE BEHAVIOR OF THE SUTURE MATERIAL. THE AVERAGE KNOT PULL TENSILE STRENGTH VALUE OF THE RETAIN SAMPLE AND VALUE AT RELEASE WAS FOUND TO MEET THE IN-HOUSE AVERAGE KNOT PULL TENSILE STRENGTH REQUIREMENT. ALL THE INDIVIDUAL AS WELL AS AVERAGE KNOT PULL TENSILE STRENGTH VALUES WERE FOUND TO MEET THE IN-HOUSE SPECIFICATION REQUIREMENTS. PER THE ANALYSIS THERE WAS NO ISSUE RELATED TO PROCESSING OF THE LOT. ALL THE VALUES ARE WITHIN THE CONTROL LIMITS.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE OFF FROM THE SWAGED POINT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977354 PDS II POLYDIOXANONE SUTURE SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. T5001

    Patients

    Seq Age Sex Outcome Treatment
    1