BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARCO HEADED DRILL BIT 6.5MM

    MDR report key: 2630928 · Received June 25, 2012

    Report

    Report Number
    8043862-2012-00008
    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 Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BROKEN DRILL HAS BEEN CHECKED BY THE SUPPLIER IN DETAIL. NO DEVIATION HAS BEEN IDENTIFIED FROM THE SPECIFICATION. THE SUPPLIER ASSUMES THAT THE DRILL COLLIDED WITH SOMETHING MADE OF METAL DURING SURGERY WHICH COULD BE THE DRILL GUIDE OR ANOTHER IMPLANT THAT HAS BEEN IMPLANTED BEFORE. UNFORTUNATELY THE DISTRIBUTOR (B)(4) DID NOT PROVIDE ANY INFO.

    Description of Event or Problem · 1

    ALLEGEDLY THE DRILL BITS FAILED/BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DARCO HEADED DRILL BIT 6.5MM DRILL HTW AAP IMPLANTATE AG IW706522 W002

    Patients

    Seq Age Sex Outcome Treatment
    1