BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI 11X180MM X 130

    MDR report key: 2132227 · Received June 14, 2011

    Report

    Report Number
    9610622-2011-00260
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    FELL ON ICE (PRIMARY FRACTURE). SLIPPED IN SNOW AT THE CURB AND SUSTAINED A REVERSE OBLIQUE SUBTROCHANTERIC FEMUR FRACTURE (RT). SHE WAS TAKEN TO SURGERY AND A GAMMA NAIL WAS PLACED. PATIENT STARTED TO GET PAIN. CT WAS TAKEN TO REVEAL A NON UNION ALSO AN ADDITIONAL FRACTURE OF THE TROCHANTERIC PORTION. BROKEN HARDWARE IS SUSPECTED. TOOK HARDWARE OUT CONFIRMED BROKEN HARDWARE. IT WAS REPORTED, THE NON UNION BROKE IN THE PROXIMAL HARDWARE. THE PROXIMAL PART OF THE GAMMA NAIL WHERE THE LAG SCREW GOES THROUGH SNAPPED IN HALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC NAIL KIT, TI 11X180MM X 130 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K109721

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention