BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLORADO NEEDLE, 3" STRAIGHT SLEEVE, 3MM 45 ANG

    MDR report key: 3841530 · Received May 30, 2014

    Report

    Report Number
    0008010177-2014-00142
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-CORK
    Product Code
    GEI
    PMA / PMN Number
    K033232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE VISUAL INVESTIGATION OF THE PICTURE PROVIDED CONFIRMED THAT THE TIP OF THE NEEDLE IS MISSING/BROKEN OFF. BECAUSE THE COMPLAINED DEVICE WAS NOT RETURNED IT WAS NOT POSSIBLE TO PERFORM FURTHER INVESTIGATIONS. THE REVIEW OF THE RELATED MANUFACTURING (BY THE SUPPLIER) AND INSPECTION DOCUMENTS (BY (B)(4)) SHOWED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE SPECIFICATION. THE SUPPLIER TEAM HAS COMPLETED A THOROUGH INVESTIGATION OF ALL THE ASSOCIATED PROCESSING STEPS AND THE RELATED MATERIALS (INPUTS AND OUTPUTS). BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. AS PER STATISTICAL EVALUATION THERE WERE NO INDICATIONS FOR ANY SYSTEMATIC, DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE.

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILST IN SURGERY, THE TIP OF A COLORADO NEEDLE HAS BROKEN OFF. THE TIP COULD NOT BE FOUND AND THE PATIENT REQUIRED AN X-RAY TO SEE IF IT HAD FALLEN IN THE WOUND. THE X-RAY WAS INCONCLUSIVE AND THEY ARE STILL UNAWARE OF WHERE THE TIP OF THE NEEDLE IS. THIS RESULTED IN A DELAY TO SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILST IN SURGERY, THE TIP OF A COLORADO NEEDLE HAS BROKEN OFF. THE TIP COULD NOT BE FOUND AND THE PATIENT REQUIRED AN X-RAY TO SEE IF IT HAD FALLEN IN THE WOUND. THE X-RAY WAS INCONCLUSIVE AND THEY ARE STILL UNAWARE OF WHERE THE TIP OF THE NEEDLE IS. THIS RESULTED IN A DELAY TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318380 COLORADO NEEDLE, 3" STRAIGHT SLEEVE, 3MM 45 ANG INSTRUMENT GEI STRYKER ORTHOPAEDICS-CORK 13275017

    Patients

    Seq Age Sex Outcome Treatment
    1