BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS 4:1 MODULAR CAPTURE

    MDR report key: 2233068 · Received July 26, 2011

    Report

    Report Number
    2249697-2011-01121
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 14, 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
    AU
    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

    (B)(6) NURSE OF THE HOSPITAL REPORTED TO OUR SALES REP (B)(4) THAT SHE WAS OBSERVING A SURGERY PROCEDURE. DURING THIS SHE OBSERVED THAT THE MODULAR CAPTURE WAS FALLEN DOWN AND BROKEN INTO ALL COMPONENTS. THERE WAS A DELAY OF ONE MINUTE BECAUSE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIS 4:1 MODULAR CAPTURE INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other