BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL IMPACTOR EXTRACTOR

    MDR report key: 2922713 · Received December 28, 2012

    Report

    Report Number
    2249697-2012-02820
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY A PIN/RIVET THAT HOLDS ONE OF THE ARMS IN PLACE FELL OUT OF THE IMPACTOR EXTRACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL IMPACTOR EXTRACTOR INSTRUMENT HWA STRYKER ORTHOPAEDICS MAHWAH NA RD6M099

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R