BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELAN 4 1-RING DIAMOND BURR X-COARSE D6.0

    MDR report key: 6368061 · Received March 1, 2017

    Report

    Report Number
    9610612-2017-00073
    Event Type
    Malfunction
    Date Received
    March 1, 2017
    Report Date
    March 1, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018 . MANUFACTURING SITE EVALUATION: SEVERAL AREAS WITH MISSING DIAMONDS ARE VISIBLE. A SAFETY TEAM WAS CONVENED. IT CAN BE ASSUMED THAT THE FAILURE WAS CAUSED BY A CHANGE OF THE MANUFACTURING PROCESS. SINCE THIS CHANGE, THE BURRS WERE NO LONGER BRUSHED AFTER THE COATING TO REMOVE THE LOOSE DIAMONDS. DUE TO THIS REASON, THE RISK OCCUR THAT THE DIAMONDS CAN DETACH OF THE BURR. A PATIENT HAZARD CANNOT BE ASSESSED AT THIS STAGE, THUS THE FOLLOWING TASK WERE INITIATED: CREATION OF A RISK ASSESSMENT. STATEMENT OF THE MANUFACTURER. BLOCKING OF THE WAREHOUSE. CLINICAL EVALUATION. FORWARD A LIST OF REQUIREMENTS TO MANUFACTURER. DETECTION OF REMAINING NICKEL ON LOOSENED DIAMOND. FOLLOW-UP SAFETY TEAM. THE PRODUCT DOES NOT REQUIRE BATCH MANAGEMENT; A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE. BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY A MANUFACTURING ERROR.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: GERMANY. IT WAS REPORTED THAT THREE BURRS HAD MISSING DIAMONDS. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2017-00071, 9610612-2017-00072.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152610 ELAN 4 1-RING DIAMOND BURR X-COARSE D6.0 HIGH SPEED POWER SYSTEMS GEY AESCULAP AG GP176R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other