BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGIDFIX 7MM FEMORAL ROD

    MDR report key: 1182709 · Received September 25, 2008

    Report

    Report Number
    1221934-2008-00459
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AWAITING RECEIPT OF THE COMPLAINT DEVICE TOWARDS CONDUCTING A ROOT CAUSE ANALYSIS. WHEN THE EVALUATION IS COMPLETE, THE FINDINGS WILL BE THE SUBJECT OF THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR REP REPORTS THAT DURING A KNEE REPAIR, THE SURGEON OBSERVED METAL FILINGS EMANATING FROM THE DISTAL END OF A 7MM FEMORAL ROD AND FALLING INTO THE BONE TUNNEL. ALL OF THE DEBRIS WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. COMPLAINT DEVICES DISCARDED BY USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGIDFIX 7MM FEMORAL ROD ARTHROSCOPIC INSTRUMENT HRX DEPUY MITEK 213707 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK