BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCULAN 3TI DRILL ATTACHM. LARGE JACOBS

    MDR report key: 3883061 · Received February 19, 2014

    Report

    Report Number
    2916714-2014-00096
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Report Date
    February 17, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MANUFACTURING SITE EVALUATION: THE DETECTED FAILURE (BROKEN TEETH) IS RELATED TO THE MATERIAL USED FOR THE CHUCK OF THE ADAPTOR. CAPA INITIATED AT ORIGINAL MANUFACTURING SITE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). TOOTH BROKE OFF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103866 ACCULAN 3TI DRILL ATTACHM. LARGE JACOBS HWE AESCULAP AG & CO. KG GB638R 51975754

    Patients

    Seq Age Sex Outcome Treatment
    1 Other