BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL STEM INSERTER/EXTRACT

    MDR report key: 1811514 · Received August 17, 2010

    Report

    Report Number
    2249697-2010-01108
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 29, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PUT THE STEM ON THE STEM INSERTER, AND DR WENT TO INSERT THE STEM AND THE THREADED END BROKE OFF, LEAVING THE THREADS IN THE STEM. REP WAS GOING TO GET ANOTHER STEM, BUT WHILE HE WENT TO DO THAT, THE DR WAS ABLE TO GET THE THREADS OUT, AND SO CONTINUED THE SURGERY WITH THE ORIGINAL STEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL STEM INSERTER/EXTRACT INSTRUMENT JWH STRYKER ORTHOPAEDICS MAHWAH NA TAXE119

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention