BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL SHD ANGLED DRIVER

    MDR report key: 1984578 · Received January 28, 2011

    Report

    Report Number
    1818910-2011-00644
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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 A REAM AND RUN PROCEDURE, THE REAMER HANDLE LOCKED UP, CAUSING IT NOT TO SPIN THE REAMER ATTACHED TO IT. AS THE SURGEON WAS TORQUING ON IT TO MAKE IT SPIN, IT CAUSED SOME DEBRIS TO ESCAPE FROM THE HANDLE, WHICH WAS FOUND ON POST-OP XRAYS IN THE PT'S ARM. THE PROBLEM WITH THE REAMER HANDLE ALSO CAUSED A 20-MINUTE SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL SHD ANGLED DRIVER 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA A0805A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA