BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNATURE INSTRUMENTATION

    MDR report key: 2020801 · Received March 8, 2011

    Report

    Report Number
    2020801
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 2, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LEFT KNEE REPLACEMENT,THE SPRING PIN USED TO PREPARE THE FEMUR AND HOLD CUTTING GUIDES IN PLACE APPARENTLY BROKE. THE BROKEN SPRING PIN WAS FOUND AFTER THE COMPLETION OF THE PROCEDURE. POST OP X-RAY CONFIRMED THE THREADED PORTION OF THE SPRING DRILL PIN HAD FRACTURED AND WAS RETAINED BY THE PATIENT.====================== MANUFACTURER RESPONSE FOR SPRING DRILL PIN, SIGNATURE INSTRUMENTATION======================UNABLE TO ASSESS AS BROKEN PORTION DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNATURE INSTRUMENTATION SPRING DRILL PIN JWH BIOMET ORTHOPEDICS * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR