BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY VERSANAIL

    MDR report key: 1062428 · Received June 6, 2008

    Report

    Report Number
    1062428
    Event Type
    Malfunction
    Date Received
    June 6, 2008
    Date of Event
    May 25, 2008
    Report Date
    June 6, 2008
    Manufacturer
    DEPUY ORTHOPEDICS, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 13MM FLEXIBLE REAMER BROKE DISTALLY, REAMER TIP LEFT IN FEMORAL CANAL, EXTRACTED WITH BALL TIP GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY VERSANAIL SCREW HWC DEPUY ORTHOPEDICS, INC. VERSANAIL *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR