BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4522661 · Received February 5, 2015

    Report

    Report Number
    4522661
    Event Type
    Malfunction
    Date Received
    February 5, 2015
    Date of Event
    February 2, 2015
    Report Date
    February 5, 2015
    Manufacturer
    BIOMET SPINE LLC
    Product Code
    HXC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING FINAL CLOSING COUNT FOLLOWING SPINAL FUSION AND IMPLANT REMOVAL, SCRUB TECH NOTICED A PIECE OF METAL ON THE STERILE FIELD AT THE LOCATION OF THE PATIENT'S LEGS. A COMPLETE ASSESSMENT OF THE INSTRUMENT WAS PERFORMED AND IT WAS DISCOVERED TO HAVE COME FROM THE INSIDE OF THE EBI T-HANDLE WRENCH. THE METAL THAT BROKE OFF WAS A SMALL SECTION AND IT WAS UNCLEAR IF MORE HAD BROKEN OFF DURING THIS USE. THE ENTIRE WOUND AREA WAS EXAMINED WITH IMAGING TO ENSURE THERE WERE NO OTHER PIECES. ALL IMAGING WAS NEGATIVE. THE PATIENT WAS NOT HARMED.======================MANUFACTURER RESPONSE FOR TORQUE WRENCH, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================REQUESTED ITEM FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84519 * TORQUE WRENCH HXC BIOMET SPINE LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR