BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HED DDRIVER, 2.5 MM

    MDR report key: 1660966 · Received April 12, 2010

    Report

    Report Number
    1221934-2010-00149
    Event Type
    Malfunction
    Date Received
    April 12, 2010
    Date of Event
    April 6, 2010
    Report Date
    April 6, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    HXX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A F/U REPORT.

    Description of Event or Problem · 1

    OUR REP IS REPORTING THAT DURING KNEE REPAIR, A PORTION OF THE DISTAL TIP OF THE HEXDRIVER BROKE OFF INTO THE SCREW. THE FRAGMENT WAS EASILY RETRIEVED FROM THE JOINT SPACE, 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 HED DDRIVER, 2.5 MM ARTHROSCOPIC INSTRUMENT HXX DEPUY MITEK 219124 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK