BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL, TRI-FLAT T2 FEMUR 4,2X340MM

    MDR report key: 2934106 · Received December 19, 2012

    Report

    Report Number
    9610622-2012-00604
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS RETURNED TO DISTRIBUTION CENTER IN THE STATE THAT IT DAMAGED. THE SUBSEQUENT SURGERY WAS NOT AFFECTED. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL, TRI-FLAT T2 FEMUR 4,2X340MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KKM815918

    Patients

    Seq Age Sex Outcome Treatment
    1 Other