BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARCO HEADED DRILL BIT 6.5MM

    MDR report key: 2630984 · Received June 25, 2012

    Report

    Report Number
    8043862-2012-00012
    Event Type
    Malfunction
    Date Received
    June 25, 2012
    Report Date
    June 21, 2012
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HTW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL BIT WAS SENT BACK AND VISUALLY INSPECTED. THE DEVICE HISTORY RECORD WAS CHECKED AND SHOWED NO DEVIATION FROM THE SPECIFICATION. THE CHARACTERISTIC OF THE DAMAGE IS MORE RELATED TO AN UNPROPER HANDLING OF THE DRILL BIT BY THE SURGEON.

    Description of Event or Problem · 1

    ALLEGEDLY DRILL BIT BROKE IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DARCO HEADED DRILL BIT 6.5MM DRILL HTW AAP IMPLANTATE AG IW706522 W003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention