BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBRIJET BIOMATERIALS APPLICATOR

    MDR report key: 2650472 · Received June 28, 2012

    Report

    Report Number
    2183425-2012-00001
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Date of Event
    June 6, 2012
    Report Date
    June 28, 2012
    Manufacturer
    MICROMEDICS, INC.
    Product Code
    KYZ
    PMA / PMN Number
    K881020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DETACHMENT OF DEVICE OR COMPONENT. IT WAS REPORTED THAT A SPRAY TIP BECAME DETACHED FROM THE APPLICATOR DURING A TOTAL KNEE REPLACEMENT SURGERY. THE SPRAY TIP WAS DETECTED DURING A STANDARD POST-OPERATIVE X-RAY AND WAS SURGICALLY REMOVED. THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBRIJET BIOMATERIALS APPLICATOR SYRINGE, IRRIGATING, NON-DENTAL KYZ MICROMEDICS, INC. SA-3675 125808

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention