BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARCO HEADED DRILL BIT 6.5MM

    MDR report key: 2630983 · Received June 25, 2012

    Report

    Report Number
    8043862-2012-00011
    Event Type
    Malfunction
    Date Received
    June 25, 2012
    Report Date
    June 21, 2012
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL BIT WAS SENT BACK AND VISUALLY INSPECTED. DEVICE HISTORY RECORD WAS CHECKED AND SHOWED NO DEVIATION. THE CHARACTERISTIC OF THE DAMAGE IS MORE RELATED TO AN UNPROPER HANDLING OF THE DRILL BIT BY THE SURGEON. THE SURGEON STATED THAT ALL FRAGMENTS OF THE DRILL WERE REMOVED FROM THE PT. THEREFORE, THE FILE HAS BEEN CLOSED.

    Description of Event or Problem · 1

    ORIGINAL SURGERY AND REVISION DATE UNK. ALLEGEDLY, 4.4 DRILL BIT WAS BEING USED IN AN ANKLE FUSION CASE. THE PT HAD A PREVIOUS SURGERY WHERE 2 EACH 4.0MM CANNULATED SCREWS HAD BEEN IMPLANTED. THE SURGEON HAD IMPLANTED THE X-WIRE (2.5MM SMOOTH) AND CLEARED THE 4.0MM SCREWS. AS HE DRILLED NORMALLY WITH THE 4.4MM DRILL BIT, THE BIT SHATTERED INTO 4 PIECES. THE PIECES WERE RETRIEVED AND NO ADVERSE EFFECT WAS CAUSED TO THE PT. ANOTHER 4.0MM DRILL BIT WAS USED AND A 6.5MM SCREW WAS SUCCESSFULLY IMPLANTED. THE PREVIOUSLY MENTIONED 4.0MM SCREWS WERE IMPLANTED IN THE MEDIAL MALLEOLUS.

    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