BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHARD ALLEN 1/2 CIRCLE TAPER POINT (HEAVY)

    MDR report key: 1032293 · Received April 21, 2008

    Report

    Report Number
    1836161-2008-00001
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 10, 2008
    Report Date
    April 6, 2008
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY USED A NEEDLE DRIVER TO HELP PUSH THE NEEDLE THROUGH TISSUE AND TENDONS. THE PRODUCT WAS NOT RETURNED TO ASPEN FOR EVALUATION.

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A TENDON BICEP REPAIR OF SHOULDER. DURING THE PROCEDURE, THE EYED PORTION OF THE NEEDLE BROKE AND WAS UNABLE TO BE RECOVERED FROM THE PATIENT'S SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RICHARD ALLEN 1/2 CIRCLE TAPER POINT (HEAVY) NEEDLE, SURGICAL, EYED FMI ASPEN SURGICAL PRODUCTS, INC. 216701 2009-12-07

    Patients

    Seq Age Sex Outcome Treatment
    1