BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AAP DRILL BIT

    MDR report key: 4172162 · Received October 7, 2014

    Report

    Report Number
    8043862-2014-00015
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL BIT BROKE NEARLY AT THE END OF THE SPIRAL. THE DRILL BIT WILL BE SENT TO AN EXTERNAL LAB TO ELIMINATE ANY DOUBTS RELATED TO THE MATERIAL AND THE PRODUCTION PROCESS. PROBABLY THE REASON FOR THE FAILURE IS THAT THE PRODUCT HAS BEEN USED OVER YEARS.

    Description of Event or Problem · 1

    DRILL BIT BROKE DURING SURGERY. NO INFO HAS FORWARDED IF PARTS OF THE DRILL BIT REMAINED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629038 AAP DRILL BIT DRILL BIT HTW AAP IMPLANTATE AG I015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other