BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE BONE, HALL BLADE, OSCILLATING

    MDR report key: 1656703 · Received April 5, 2010

    Report

    Report Number
    1017294-2010-00048
    Event Type
    Malfunction
    Date Received
    April 5, 2010
    Date of Event
    December 11, 2009
    Report Date
    March 22, 2010
    Manufacturer
    CONMED LINVATEC
    Product Code
    KFK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THIS BLADE AND PACKAGING WAS RECEIVED FOR EVALUATION. A VISUAL EXAMINATION CONFIRMED A HOLE IN THE PACKAGE WITH POTENTIAL BREACH IN PRODUCT STERILITY. THE CAUSE OF THIS FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    OUR (B)(4) DISTRIBUTOR REPORTED FINDING A DEFECT IN THE PACKAGE CONTAINING THIS STERILE BLADE. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR SURGICAL DELAY RESULTING FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE BONE, HALL BLADE, OSCILLATING BLADE, SAW, GENERAL & PLASTIC SURGERY KFK CONMED LINVATEC 100134

    Patients

    Seq Age Sex Outcome Treatment
    1