BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDOFIL 3/0 (2) 2X40CM HS18/GS40

    MDR report key: 6671323 · Received June 27, 2017

    Report

    Report Number
    3003639970-2017-00338
    Event Type
    Malfunction
    Date Received
    June 27, 2017
    Date of Event
    May 31, 2017
    Report Date
    July 7, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE THAT IS REGISTERED WITHIN THE U.S. AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT DURING KNOTTING THE THREAD BROKE EASILY.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 1 UNOPENED UNIT AND 2 OPENED. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) OF THIS BATCH. THERE ARE NO UNITS IN OUR STOCK. BATCH MANUFACTURING RECORD OF THE INVOLVED REFERENCE-BATCH HAS BEEN CHECKED AND NO DEVIATIONS HAVE BEEN FOUND. WE HAVE RECEIVED ONE CLOSED SAMPLE AND TWO OPEN SAMPLES (WITHOUT PACK). ONE OF THE OPEN SAMPLES RECEIVED HAS THE STRAIGHT NEEDLE (GS40) DETACHED FROM THE THREAD AND IN THE OTHER OPEN SAMPLE RECEIVED THE THREAD IS BROKEN. WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE CLOSED SAMPLE RECEIVED AND THE RESULTS FULFIL PRODUCT SPECIFICATIONS (> 6.7 N IN AVERAGE AND > 3.3 N IN MINIMUM): GS40 NEEDLE: XI= 12.6 N; HS18 NEEDLE: XI= 22.7 N. WE HAVE ALSO TESTED THE LINEAR BREAKING STRENGTH OF THE THREAD OF THE CLOSED SAMPLE RECEIVED AND THE RESULTS FULFIL PRODUCT SPECIFICATIONS (> 13.4 N): 21 N IN AVERAGE AND 17.7 N IN MINIMUM. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE CLOSED SAMPLE RECEIVED FULFIL THE PRODUCT SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450238 TENDOFIL 3/0 (2) 2X40CM HS18/GS40 SUTURES GAR B.BRAUN SURGICAL SA 992127 217103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other