BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLORADO NEEDLE, 3 CM STRAIGHT (3/32") SLEEVE

    MDR report key: 4223076 · Received November 4, 2014

    Report

    Report Number
    0008010177-2014-00308
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 6, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-CORK
    Product Code
    GEI
    PMA / PMN Number
    K033232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE VISUAL INSPECTION CONFIRMED THE REPORTED EVENT THAT THE ISOLATION IS CRACKED. IN ADDITION FURTHER DAMAGES WERE IDENTIFIED CLEARLY INDICATING THAT THE DEVICES HAVE BEEN USED BEFORE. THE MASTER LABEL ON THE N103A PRODUCT AS WELL AS THE RELATED IFU STATE THAT THE PRODUCT IS SINGLE USE ONLY AND IS NOT TO BE RE-STERILIZED. THEREFORE THE ROOT CAUSE CAN BE ATTRIBUTED TO AUTOCLAVING AND MULTIPLE USE. SUMMARIZING THE INVESTIGATION THE FAILURE MODE (CRACKED ISOLATION) CAN BE ATTRIBUTED TO A USER RELATED ROOT CAUSE (MISUSE - REUSE OF SINGLE USE DEVICES). NO INDICATIONS FOR ANY DESIGN, MATERIAL OR MANUFACTURING RELATED PROBLEMS WERE FOUND IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COLORADO NEEDLE'S RED INSULATION WAS SPLITTING AND THAT AS A RESULT, THE NEEDLES WERE NOT WORKING AS DIRECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COLORADO NEEDLE'S RED INSULATION WAS SPLITTING AND THAT AS A RESULT, THE NEEDLES WERE NOT WORKING AS DIRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705562 COLORADO NEEDLE, 3 CM STRAIGHT (3/32") SLEEVE INSTRUMENT GEI STRYKER ORTHOPAEDICS-CORK 1275

    Patients

    Seq Age Sex Outcome Treatment
    1