BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATELLA DRILL TEMPLATE-CEM TD 9+11

    MDR report key: 1082423 · Received July 21, 2008

    Report

    Report Number
    2249697-2008-00209
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    STRYKER ORTOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THAT IT IS LIKELY THAT THE DEVICE FRACTURED IN AN OVERLOAD CONDITION FROM MISUSE. INSPECTION OF THE FRACTURE SURFACE ON THE BODY OF THE PATELLA DRILL INDICATED THE SPIKE FRACTURE INITIATED FROM THE MEDIAL PORTION OF THE DEVICE AND PROPAGATED LATERALLY. THIS IS THE FIRST REPORTED EVENT OF THIS NATURE SINCE THE DEVICE WAS RELEASED IN 1999. THIS IS BELIEVED TO BE AN ISOLATED EVENT. IF ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING THE SURGERY, WHEN THE SURGEON USED THE PATELLA DRILL TEMPLATE, THE SMALL PEG CAME OFF FROM IT, BUT WAS COMPLETELY REMOVED FROM PT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATELLA DRILL TEMPLATE-CEM TD 9+11 INSTRUMENT LXH STRYKER ORTOPAEDICS MAHWAH NA 26641401

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other