BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGHT BENDING IRON - 5.5

    MDR report key: 4765105 · Received March 18, 2015

    Report

    Report Number
    4765105
    Event Type
    Malfunction
    Date Received
    March 18, 2015
    Date of Event
    February 20, 2015
    Report Date
    March 18, 2015
    Manufacturer
    BIOMET SPINE, LLC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    A PIECE OF METAL BROKE OFF OF A ROD BENDER. THE PHYSICIAN NOTICED THE INSTRUMENT WAS CHIPPED AND STAFF WAS UNABLE TO FIND BROKEN PIECE OF INSTRUMENT. AN INTRAOPERATIVE C-ARM WAS USED TO SEE IF THE BROKEN PIECE OF INSTRUMENT FELL INTO THE SURGICAL WOUND. THE SURGICAL TEAM DISCUSSED HAVING A WET READ PERFORMED SO THAT RADIOLOGIST COULD DETERMINE THAT THE WOUND IS FREE OF ANY FOREIGN OBJECTS. THE PHYSICIAN AGREED AND A VERBAL ORDER WAS ENTERED FOR AN ABDOMINAL AND CHEST X-RAY. THE NSTRUMENT WAS SENT TO STERILE PROCESSING DEPARTMENT (SPD) FOR PROPER CLEANING AND GIVEN TO DEPARTMENT MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186071 RIGHT BENDING IRON - 5.5 ORTHOPEDIC MEDICAL SURGICAL INSTRUMENT LXH BIOMET SPINE, LLC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR