BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE OFFSET RASP HANDLE

    MDR report key: 2002966 · Received February 8, 2011

    Report

    Report Number
    2249697-2011-00131
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 11, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THEATRE NURSE REPORTS VIA OUR SALES REP, THAT THE LEVER BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE OFFSET RASP HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA PZW04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention