BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125

    MDR report key: 2749795 · Received September 14, 2012

    Report

    Report Number
    9610622-2012-00411
    Event Type
    Injury
    Date Received
    September 14, 2012
    Date of Event
    August 27, 2012
    Report Date
    August 27, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    034223
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: LAG SCREW, TI GAMMA3 10.5X105MM, CATALOG: 3060-0105S, LOT K237177. LOCKING SCREW, FULLY THREADED T2 TIBIA 5X37, 5MM, CATALOG: 1896-5037S, LOT: K593566. END CAP, STD, TI GAMMA3, CATALOG: 3005-1100S, LOT: K104451. SET SCREW, TI GAMMA3 8X17.5MM, CATALOG: 3003-0822S, LOT: K171650.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, A G3 EXTRACTION WAS PERFORMED BECAUSE OF A NON UNION. WHEN THE NAIL WAS EXTRACTED, IT TURNED OUT THAT IT HAS BROKEN. THE PRIMARY OPERATION WAS PERFORMED IN (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K171650

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other| R