BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE WAX 24X2.5G

    MDR report key: 6125997 · Received November 23, 2016

    Report

    Report Number
    2916714-2016-00962
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Report Date
    November 17, 2016
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MTJ
    PMA / PMN Number
    K000021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 4 UNOPENED UNITS (EACH ONE OF ONE DIFFERENT BATCH). ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF ANY OF THE INVOLVED CODE-BATCHES. MANUFACTURED (B)(4) UNITS OF THE BATCH 216034, (B)(4) UNITS OF THE BATCH 215492, (B)(4) UNITS OF THE BATCH 216104 AND (B)(4) UNITS OF THE BATCH 216102. THERE ARE NO UNITS IN STOCK OF ANY OF THE BATCHES. BATCH MANUFACTURING RECORDS OF THE INVOLVED REFERENCE-BATCHES HAVE BEEN CHECKED AND NO DEVIATIONS HAVE BEEN FOUND. THE FOLLOWING PARAMETERS OF EACH SAMPLE RECEIVED AND OTHER THREE DIFFERENT BATCHES HAVE BEEN TESTED: SMELL, COLOR, APPEARANCE, SUPPLENESS AND ADHESIVE BEHAVIOR. ALL BATCHES ARE INTO THE CURRENT RANGE FOR THIS PRODUCT. NO DIFFERENCES HAVE BEEN FOUND BETWEEN THE DIFFERENT BATCHES ANALYZED: THE SMELL IS THE USUAL ONE, THERE IS NOT SMELL RANCID. THE COLOR IS WHITE YELLOW AS USUAL. THE APPEARANCE IS ACCORDING TO THE VISUAL STANDARD. REGARDING THE SUPPLENESS, THE PRODUCTS CAN BE KNEADED WELL. -AND CONCERNING THE ADHESIVE BEHAVIOR, THE PRODUCT HOLD WELL ON INSTRUMENTS. FINAL CONCLUSION: COMPLAINT IS NOT JUSTIFIED. RESULTS OF THE SAMPLES RECEIVED FULFILLS THE OEM REQUIREMENTS. NOTE IS TAKEN OF THIS INCIDENT 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.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: UNITED KINGDOM. IT WAS REPORTED THAT THERE IS A PROBLEM WITH THE BONE WAX, THE PRODUCT CRUMBLES UPON USE. THE PRODUCT DOES NOT STICK WELL TO THE INSTRUMENTS AND IS NOT EFFECTIVE. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 2916714-2016-00960, 2916714-2016-00961, 2916714-2016-00962.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776182 BONE WAX 24X2.5G BONE WAX MTJ B.BRAUN SURGICAL SA 1029754 216102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other