BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLADE 1884507 RADENOID 5PK ADULT 4.5MM

    MDR report key: 1530901 · Received November 4, 2009

    Report

    Report Number
    1045254-2009-00048
    Event Type
    Other
    Date Received
    November 4, 2009
    Date of Event
    October 6, 2009
    Report Date
    October 6, 2009
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDWATCH FORM WAS NOT RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFO NOT BEING PROVIDED OR RELEASED BY THE REPORTER DESPITE ATTEMPTS TO OBTAIN THE REQUIRED INFO. THIS PRODUCT WAS BEING USED FOR TREATMENT. THIS REPORT IS BEING FILED BECAUSE INTERVENTION WAS REQUIRED TO REMOVE TWO DEVICE PIECES DURING THE SAME PROCEDURE. A REVIEW OF THE COMPLAINT HISTORY INDICATES THIS IS THE FIRST REPORT FOR THIS PRODUCT LOT AND NO ANOMALIES WERE FOUND IN THE MFG DOCUMENT. THE ENTIRE BLADE WAS RETURNED INCLUDING THE PIECES AND THE ANALYSIS WAS PERFORMED. VISUAL INSPECTION SHOWED ONE OPENED AND USED PIECE HAD WEAR MARKS ON THE OUTSIDE OF THE INNER TUBE INDICATING SIDE LOADING. THE EXCESSIVE PRESSURE CAUSED THE INNER BLADE TO BREAK FROM RUBBING AGAINST THE OUTER BLADE. THE INSTRUCTIONS FOR USE STATES THAT EXCESSIVE PRESSURE APPLIED TO THE DEVICE MAY CAUSE THE DEVICE TO FRACTURE. SHOULD A FRACTURE OCCUR DURING USE, EXTREME CARE MUST BE EXERCISED TO ENSURE THAT ALL FRAGMENTS ARE RETRIEVED AND REMOVED FROM THE PT. UNREMOVED FRAGMENTS MAY CAUSE TISSUE DAMAGE TO THE PT.

    Description of Event or Problem · 1

    DURING SURGERY, TWO LARGE PIECES BROKE OFF AND WERE EASILY REMOVED FROM THE SURGICAL SITE. THE PROCEDURE WAS NOT DELAYED AND WAS COMPLETED WITH ANOTHER BLADE. THE PT IS FINE AND NO OTHER PROCEDURES WERE PERFORMED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADE 1884507 RADENOID 5PK ADULT 4.5MM 77EQJ EQJ MEDTRONIC XOMED, INC. 1884507 61869400

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention