BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHARDS CUP IMPACTOR

    MDR report key: 1883939 · Received October 4, 2010

    Report

    Report Number
    1883939
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 4, 2010
    Manufacturer
    SMITH AND NEPHEW RICHARDS INC.
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    A METAL SHARD FROM THE SCREW THREADS AT THE TIP OF THE IMPACTOR CAME LOOSE AND CUT THE SCRUB TECHNICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RICHARDS CUP IMPACTOR ACETABULAR CUP IMPACTOR HWA SMITH AND NEPHEW RICHARDS INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *