BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA.

    MDR report key: 1925116 · Received November 23, 2010

    Report

    Report Number
    2249697-2010-01618
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    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

    IT WAS REPORTED, "NURSE (B)(6) , HEAD OF THEATRE, REPORTS VIA OUR SALES REP, (B)(6), THAT THE BACKWARD SPIGOT BROKE OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. INSTRUMENT JWH STRYKER ORTHOPAEDICS MAHWAH NA SB2V25

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other