BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GSH INTRAMEDULLARY NAIL 12 MM DIA 25 CM LONG

    MDR report key: 105197 · Received July 14, 1997

    Report

    Report Number
    MW1011683
    Event Type
    Injury
    Date Received
    July 14, 1997
    Date of Event
    February 2, 1996
    Report Date
    July 2, 1997
    Manufacturer
    SMITH AND NEPHEW RICHARDS, INC.
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A GSH NAIL 25 CM. LONG & 12 MM DIAMETER WAS INSERTED RETROGRADE INTO THE INTRAMEDULLARY CANAL OF THE FEMUR FOR A FRACTURE (PARTIALLY DISPLACED) AT 12.5 CM. ABOVE THE KNEE JOINT. SAID NAIL CONTAINED 12 EACH PREDRILLED SCREW HOLES. THREE CROSS SCREWS WERE USED ABOVE & 3 BELOW THE FRACTURE. AN EMPTY SCREW HOLE WAS LOCATED EXACTLY EVEN WITH THE FRACTURE. NAIL INSERTED ON 9-12-95. AMBULATION WITH CRUTCH & THEN A CANE BEGAN ON 12-18-95. THE NAIL SHEARED AT THE FRACTURE SITE AND THROUGH THE EMPTY SCREW HOLE ON 2-2-96, WHILE WALKING ON A CARPETED FLOOR WITH USE OF A CANE. THE FRACTURE HAS HEALED WITH USE OF A CAST BRACE, BUT IS CRIPPLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GSH INTRAMEDULLARY NAIL 12 MM DIA 25 CM LONG Implant INTRAMEDULLARY NAIL HSB SMITH AND NEPHEW RICHARDS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R| S