BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED GUIDE WIRE ASNIS III Ø2.0X150MM

    MDR report key: 3141342 · Received June 3, 2013

    Report

    Report Number
    0008031020-2013-00170
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED BY THE HOSPITAL. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT DURING A CASE THE GUIDE WIRE SNAPPED OFF IN THE PATIENT. THE SALES REP REPORTED THAT THE GUIDE WIRE WAS DRILLED INTO THE BONE AND WHEN THEY WERE TAKING THE WIRE OUT IT SNAPPED OFF STILL IN THE BONE. THE SURGEON STATED THAT THIS SHOULD NOT HAVE HAPPENED AS HE WAS USING THE CORRECT TOOLS. THE SURGEON TRIED TO REMOVE THE REST OF THE GUIDE WIRE BUT IT SNAPPED OFF. THE WIRE HAS BEEN DISCARDED BY THE HOSPITAL AS IT WAS NOT STERILE AND COULD NOT BE STERILIZED FOR SAFE TRANSIT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245111 THREADED GUIDE WIRE ASNIS III Ø2.0X150MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-SELZACH 01997Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Other