BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEMESILK

    MDR report key: 6083508 · Received November 7, 2016

    Report

    Report Number
    3003063934-2016-00001
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    March 7, 2016
    Report Date
    March 29, 2016
    Manufacturer
    DEMETECH CORPORATION
    Product Code
    GAP
    PMA / PMN Number
    K023029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON MARCH 08, 2016, WE WERE NOTIFIED BY (B)(6) THAT THE SUTURE KEPT SPLITTING OR RUPTURING DURING THE SUTURING ON LOT NUMBER WW148-14, PRODUCT CODE DT-683-1 (SK164019F4P). CONCERNING THIS EVENT, THE CORRESPONDING INVESTIGATION OF OUR MANUFACTURING AND PACKAGING PROCESSES WAS COMPLETED TO DETERMINE ROOT CAUSE AND AN APPROPRIATE CORRECTIVE/PREVENTATIVE ACTION PLAN. THE FOLLOWING IS A SUMMARY OF THE INVESTIGATION AND CONCLUSIONS DRAWN: A COMPLETE REVIEW OF THE DEVICE HISTORY RECORD ("DHR") FOR THE FINISHED PRODUCT WAS CONDUCTED. DEMESILK SIZE 4-0, PRODUCT CODE DT-683-1 (SK164019F4P), LOT NUMBER WW148-14 WAS PACKAGED ON DECEMBER 04, 2014. REVIEW OF THE DHR DID NOT INDICATE ANY ISSUES DURING THE MANUFACTURING AND PACKAGING PROCESSES. ALL IN-PROCESS TESTS MET THEIR RESPECTIVE SPECIFICATIONS AND, IN ADDITION, THE IN-PROCESS AND FINAL PRODUCT INSPECTIONS MET THE ACCEPTANCE CRITERIA. THE REVIEW INDICATED THAT THE PRODUCT WAS MADE TO MEET STANDARD PRODUCT SPECIFICATIONS WITH NO CHANGES/MODIFICATIONS TO THE STANDARD MANUFACTURING PROCESS. A REVIEW OF THE PACKAGING ACCEPTANCE QUALITY LIMITS ("AQL") INSPECTIONS THAT WERE PERFORMED DURING THE PACKAGING OF THE PRODUCT WAS CONDUCTED. DEMETECH USED AN AQL PROCEDURE BASED ON ANSI TABLES. THE QUALITY PERSONNEL DID NOT FIND ANY DEFECTS. AS PART OF OUR INVESTIGATION, WE HAVE REVIEWED AND ANALYZED THE DATA WE HAVE ON FILE WITH REGARD TO TESTING PERFORMED AT THE TIME OF RELEASED AND ON THE RETURNED SAMPLES. THE TESTING WAS PERFORMED IN ACCORDANCE WITH THE REQUIREMENTS OF THE UNITED STATES PHARMACOPEIA. BASED ON OUR REVIEW OF THE SAMPLES' TENSILE STRENGTH, THE DATA AT THE TIME OF PRODUCT RELEASED, AND THE RETURNED SAMPLES TESTING DATA, THE TENSILE STRENGTH AND NEEDLE PULL MET ALL OF THE USP REQUIREMENTS FOR THE LOT CORRESPONDING SUTURE SIZE REQUIREMENTS. THIS INVESTIGATION CONCLUDED THAT THE QUALITY, STRENGTH, OR INTEGRITY OF THE PRODUCT WAS NOT AFFECTED.

    Description of Event or Problem · 1

    SUTURE KEPT SPLITTING OR BREAKING DURING SUTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735249 DEMESILK SILK SUTURE GAP DEMETECH CORPORATION SK164019F4P WW148-14

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR