BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR HEX DRIVER

    MDR report key: 1800127 · Received August 10, 2010

    Report

    Report Number
    1221934-2010-00270
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    HXX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT DURING AN ACL REPAIR, THE TIPS OF THE CUSTOMER'S 30MM AND 35MM MODULAR DRIVERS BROKE OFF INTO THE FIXATION SCREWS WHILE THE FIXATION SCREWS WERE BEING DRIVEN INTO THE BONE TUNNELS. THE FRAGMENTS WERE RETRIEVED FROM THE BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR HEX DRIVER BIO-INTRAFIX HXX DEPUY MITEK 254641 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK