BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE SENTINEL FLEXIBLE REAMER

    MDR report key: 2151333 · Received June 21, 2011

    Report

    Report Number
    1822565-2011-01453
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    November 15, 2010
    Report Date
    May 24, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REAMER BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE SENTINEL FLEXIBLE REAMER HWE ZIMMER, INC. 61247384

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR