BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL ADAPTER

    MDR report key: 1071426 · Received July 8, 2008

    Report

    Report Number
    9610622-2008-00109
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 17, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    JDS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETUNED AT THIS TIME. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE JIG WAS NOT ALIGNED WITH THE DRILL SLEEVE. THE LAG SCREWS MISSED THE HOLE IN THE NAIL. BOTH LAG SCREWS WERE POSTERIOR TO THE NAIL. PATIENT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAIL ADAPTER INSTRUMENT JDS STRYKER OSTEOSYNTHESIS KIEL NA KH1073930

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other| R