BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2090909 · Received May 12, 2011

    Report

    Report Number
    8030965-2011-00220
    Event Type
    Injury
    Date Received
    May 12, 2011
    Report Date
    May 2, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. INVESTIGATION COULD NOT BE CONCLUDED AS NO DEVICE WAS RETURNED. DATE OF MFR REPORTED AS (B)(4) 2008.

    Description of Event or Problem · 1

    WHILE REAMING THE FEMUR HEAD, THE TIP OF THE REAMER BROKE AND REMAINS IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI REAMER HTO SYNTHES GMBH 2138041

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention