BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL RASP SIZE 2.5

    MDR report key: 1780328 · Received July 26, 2010

    Report

    Report Number
    2249697-2010-00909
    Event Type
    Injury
    Date Received
    July 26, 2010
    Date of Event
    June 28, 2010
    Report Date
    July 2, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    PROF. DR. RETURNED THE RASP TOGETHER WITH A QUESTIONNAIRE AND THE SURGERY REPORT. IN THE QUESTIONNAIRE, HE STATES THAT DURING THE TRY TO KNOCK OUT THE RASP THE HOLDING BOW BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL RASP SIZE 2.5 INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention