BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 130

    MDR report key: 2622477 · Received June 14, 2012

    Report

    Report Number
    9610622-2012-00265
    Event Type
    Injury
    Date Received
    June 14, 2012
    Date of Event
    February 4, 2012
    Report Date
    June 4, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICES: (B)(4) LAG SCREW, TI GAMMA3 10.5X120 MM LOT# K218390, (B)(4) LOCKING SCREW, FULLY THREADED T2 TIBIA 5X42, 5 MM LOT# K742175, (B)(4) SET SCREW, TI GAMMA3 8X17.5 MM, LOT# K724354.

    Description of Event or Problem · 1

    IMPLANT SURGEON REPORTED TO OUR SALES REP THAT THE IMPLANTED NAIL WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 130 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K724354

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R