BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 2771556 · Received September 3, 2012

    Report

    Report Number
    2771556
    Event Type
    Injury
    Date Received
    September 3, 2012
    Date of Event
    August 24, 2012
    Report Date
    September 3, 2012
    Manufacturer
    STRYKER ORTHOPEDICS
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY 8 MONTHS PREVIOUSLY, PATIENT HAD SUSTAINED A MID SHAFT FRACTURE OF THE FEMUR IN A TRAUMATIC EVENT. FEMUR WAS REPAIRED WITH STRYKER GAMMA NAIL SYSTEM. PATIENT CONTINUED TO HAVE PAIN AND NONUNION. A FOLLOW-UP X-RAY IN AUGUST OF 2012 REVEALED A POSSIBLE FRACTURE OF THE DISTAL LOCKING SCREW AND PERSISTENT FRACTURE LUCENCY. THE PATIENT RETURNED TO HAVE THE LOCKING SCREWS REMOVED FOR DYNAMIZATION AND AUGMENTATION OF BONE HEALING OF THE NONUNION SITE. THE INFERIOR SCREW WAS NOTED TO BE BROKEN WITHIN THE NAIL. THE BROKEN SCREW HAD EXTENSION TO THE MEDIAL CORTEX OF THE DISTAL FEMUR, SO A 2 MM K-WIRE WAS USED TO TAP IT OUT ON THE LATERAL SIDE WHICH WAS THEN RETRIEVED THROUGH A SEPARATE MEDIAL INCISION. THERE WERE NO COMPLICATIONS ON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SCREW, FIXATION, BONE HWC STRYKER ORTHOPEDICS 1896-5047S K281101

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R OTHER