BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    #7 SCORPIO 4:1 CERAMIC BLOCKS

    MDR report key: 1901135 · Received November 10, 2010

    Report

    Report Number
    2249697-2010-01521
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    2249697-12/14/09/012R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - COMPLAINT HISTORY REVIEW. EVALUATION SUMMARY: A REVIEW OF THE PRODUCT EXPERIENCE REPORTING DATABASE AND COMPLAINT FILES SHOWS THAT A TREND HAS BEEN PREVIOUSLY IDENTIFIED REGARDING THE CERAMIC RAILS FRACTURING AND/OR FALLING OUT OF THE CUTTING BLOCKS. THE RESULTS OF THE INVESTIGATION PERFORMED INDICATED THAT THIS EVENT IS RELATED TO A TREND OF SIMILAR EVENTS WHERE CERAMIC RAILS HAVE FRACTURED. THE RESULTS OF THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THIS TREND IS DESIGN RELATED. CONTRIBUTING FACTORS TO THIS ROOT CAUSE INCLUDE THE DIAMETER AND PROXIMITY OF THE CERAMIC RAIL TO THE ANTERIOR AND POSTERIOR FACES OF THE CUTTING BLOCK, AS WELL AS THE ELASTIC PROPERTIES OF ALUMINUM, COMPARED TO THAT OF CERAMIC. THIS IS THE SAME EVENT AS: MFR # 2249697-2010-01520, 01522, 01523, 01524.

    Description of Event or Problem · 1

    IT WAS REPORTED, "THE CUSTOMER, (B)(6) REPORTED VIA OUR DISTRIBUTOR, TEKNO SURGICAL IN (B)(6) 2010 THAT THE UNITS FAILED UNDER (B)(4) WHEN THE CUSTOMER INSPECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 #7 SCORPIO 4:1 CERAMIC BLOCKS INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other