BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON 15MM DET.130DEG UP 180MM 5MM

    MDR report key: 6358980 · Received February 24, 2017

    Report

    Report Number
    9610612-2017-00097
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    January 16, 2017
    Report Date
    July 3, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    LRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: FRANCE. IT WAS REPORTED THAT THE DEFORMATION OF THE JAWS CAUSED THE DEVICE TO STICK DURING SURGERY. TOTAL OF TWENTY-THREE DEVICES WERE RETURNED TO THE MANUFACTURE WITH REPORT OF STICKING. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2017-00046, 9610612-2017-00094, 9610612-2017-00095, 9610612-2017-00096, 9610612-2017-00098, 9610612-2017-00099, 9610612-2017-00100, 9610612-2017-00101, 9610612-2017-00102, 9610612-2017-00103, 9610612-2017-00104, 9610612-2017-00105, 9610612-2017-00106, 9610612-2017-00107, 9610612-2017-00108, 9610612-2017-00109, 9610612-2017-00110, 9610612-2017-00111, 9610612-2017-00112, 9610612-2017-00113, 9610612-2017-00114, 9610612-2017-00115.

    Additional Manufacturer Narrative · 1

    A HARDNESS TEST WAS PERFORMED FOR THE INVESTIGATION. THERE WAS CONSISTENCY OF WEAR AND TEAR, INSUFFICIENT MAINTENANCE, DAMAGED CUTTING EDGES, BLADES PUSHED UPWARD AND SLIDERS PUSHED UPWARDS AND LOOSENED. 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 USER RELATED. ALSO AS A RESULT OF THE INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT MAINTENANCE OF THE DEVICE. A CAPA IS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138693 KERRISON 15MM DET.130DEG UP 180MM 5MM BONE PUNCHES LRY AESCULAP AG FK974R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other