BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-INTRAFIX

    MDR report key: 1914134 · Received November 15, 2010

    Report

    Report Number
    1914134
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US

    Narratives

    Description of Event or Problem · 1

    THE DEPUY 7.9 MITEK SCREW BROKE OFF ON INSERTION BY THE SURGEON. THE PARTIAL SCREW WAS RETAINED IN THE PATIENT, HOLDING THE GRAFT IN PLACE. A SPIKED ARTHREX STAPLE WAS ADDED TO SECURE THE GRAFT AS THE SURGEON BELIEVED THAT SIGNIFICANT FIXATION HAD BEEN ACHIEVED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-INTRAFIX MITEK SCREW HWC DEPUY MITEK 254624 3386543

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR