BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEFT - NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP HA

    MDR report key: 2220607 · Received July 15, 2011

    Report

    Report Number
    2249697-2011-01064
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 24, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN ADDITIONAL INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON ATTACHED THE HANDLE TO THE BROACH AND STARTED ADVANCING THE BROACH, THE LOCKING LEVER/MECHANISM ON THE HANDLE POPPED UP AND THE BROACH BECAME DISENGAGED FROM THE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEFT - NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP HA INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA P4H32

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other