BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIST DRILL D3.8, L 310, COIL 50, QUICK COUPLI

    MDR report key: 3905768 · Received May 28, 2014

    Report

    Report Number
    8043862-2014-00004
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 27, 2014
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL HAS BEEN RETURNED AND THE TOP HAS BEEN BROKEN OFF. THE TOP OF THE DRILL WAS NOT RETURNED. THE SHAFT OF THE DRILL SHOWS SEVERAL DAMAGES. PROBABLY A FOREIGN BODY IN THE DRILL GUIDE CAUSED THIS DAMAGES WHICH RESULTED IN THE BREAKAGE OF THE DRILL.

    Description of Event or Problem · 1

    DRILL BIT BROKE OFF DURING SURGERY. IT IS NOT KNOWN IF THE TOP OF THE DRILL WHICH BROKE OFF REMAINS IN THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314881 TWIST DRILL D3.8, L 310, COIL 50, QUICK COUPLI DRILL BIT HTW AAP IMPLANTATE AG IU 7438-33 L007

    Patients

    Seq Age Sex Outcome Treatment
    1 Other