BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION TOOL

    MDR report key: 2045717 · Received February 28, 2011

    Report

    Report Number
    2032499-2011-00076
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    March 26, 2009
    Report Date
    March 27, 2009
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    HWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE PRONGS WERE SLIGHTLY DEFORMED WITH USE. WHEN USED IN THIS COMPLAINT, THE DEFORMED PRONGS CAUSED THE PIN TO BE IMPINGED BEFORE GRABBING THE PIN DURING ACTUATION. THIS WAS MOST PROBABLY CAUSED BY ROUTINE WEAR AND TEAR. THE INSTRUCTIONS FOR USE CLEARLY STATE THAT ALL INSTRUMENTS SHOULD BE INSPECTED FOR DAMAGE DUE TO WEAR AND TEAR PRIOR TO USE. INITIALLY IT WAS DETERMINED THE EVENT WAS NOT REPORTABLE. ON A SUBSEQUENT RE-REVIEW, IT WAS DETERMINED THIS EVENT SHOULD HAVE BEEN REPORTED. DEVICE EVALUATION: RETURNED DEVICE WAS INSPECTED VISUALLY. OUTER SHEATH WAS REMOVED, REVEALING INNER MECHANISMS. THE PRONGS, WHICH GRAB THE IMPLANT, WERE SLIGHTLY DEFORMED. HOWEVER, THE INSTRUMENT PROVED TO BE FUNCTIONAL WHEN BENCH-TESTED. A SAMPLE IMPLANT WAS COMPRESSED EASILY USING THE RETURNED DEVICE. DURING A CASE, THE ANGLE AT WHICH THE INSTRUMENT IS HELD MAY CAUSE THE DEVICE TO MALFUNCTION.

    Description of Event or Problem · 1

    COMPRESSION TOOL WAS NOT GRABBING PULL PIN AND ALLOWING COMPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSION TOOL HWN INTERVENTIONAL SPINE, INC. 9049-00 112107-41

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention