BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MI CURVED ACET REAMER

    MDR report key: 1012976 · Received March 12, 2008

    Report

    Report Number
    1818910-2008-00610
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 11, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HTO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DURING SURGERY THE HANDLE OF THE INSTRUMENT BROKE. BLACK DUST FROM THE HANDLE WAS PRESENT IN THE WOUND WHICH WAS IRRIGATED AND ANTIBIOTICS WERE GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MI CURVED ACET REAMER 87LXH HTO DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA