BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED T-HANDLE BONE AWL III

    MDR report key: 1613592 · Received February 17, 2010

    Report

    Report Number
    1649384-2010-00035
    Event Type
    Malfunction
    Date Received
    February 17, 2010
    Date of Event
    January 19, 2010
    Report Date
    February 17, 2010
    Manufacturer
    ZIMMER SPINE
    Product Code
    HWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. PRODUCT IS AN INSTRUMENT AND NOT IMPLANTABLE. REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. EVALUATION IS PENDING UPON COMPLETED INVESTIGATION OF THE PRODUCT. DEVICE MANUFACTURE DATE IS UNKNOWN.

    Description of Event or Problem · 1

    DURING A KIT INSPECTION ON (B)(6) 2010, THE SALES REPRESENTATIVE FOUND THE PATHFINDER CANNULATED T HANDLE BONE AWL WITH THE TIP BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT. THIS MALFUNCTION HAS BEEN ASSOCIATED WITH AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED T-HANDLE BONE AWL III PATHFINDER HWJ ZIMMER SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1