BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOUNDATION KNEE INSTRUMENT

    MDR report key: 2011817 · Received February 24, 2011

    Report

    Report Number
    1644408-2011-00096
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - (B)(4) SUPPLIED A PATELLA DRILL BIT IN A LOANER SET. THE DRILL BIT IS CORRECT CATALOG NUMBER BUT WRONG DEPTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE INSTRUMENT PRIMARY QUICK CONNECT DRILL AP PATELLA JWH ENCORE MEDICAL, L.P. NA

    Patients

    Seq Age Sex Outcome Treatment
    1