BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL TIP EXTRACTOR ASSEMBLY

    MDR report key: 1571519 · Received December 21, 2009

    Report

    Report Number
    2249697-2009-00907
    Event Type
    Malfunction
    Date Received
    December 21, 2009
    Date of Event
    December 1, 2009
    Report Date
    December 1, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HWB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROCESS. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IN REVISING A OMNIFLEX MHA STEM THE STEM WAS REMOVED, BUT THE "BULLIT TIP" REMAINED IN FEMUR. THIS EXTRACTOR WAS USED TO REMOVE THE "BULLIT TIP", BUT WAS BROKEN DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISTAL TIP EXTRACTOR ASSEMBLY INSTRUMENT HWB STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK