BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATELLA CALIPER

    MDR report key: 2061990 · Received March 18, 2011

    Report

    Report Number
    2249697-2011-00343
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A DESIGN NON-CONFORMANCE WAS OBSERVED BASED ON THE RESULTS OF THE VISUAL INSPECTION. THE VISUAL INSPECTION INDICATED THAT THE DEVICES WERE RETURNED IN USED CONDITION WITH VISUAL DISCREPANCIES ATTRIBUTED TO FREQUENT USAGE. THE GREEN OVERMOLD OF THE DEVICES EXHIBITED EVIDENCE OF DEGRADATION. THE HANDLES HAD BECOME TACKY AND DISCOLORED. THE DEVICE MANUFACTURING HISTORY RECORD INDICATED THAT THE REPORTED LOT OF DEVICES WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK BETWEEN WITH NO REPORTED DISCREPANCIES. THE PRODUCT EXPERIENCE REPORTING DATABASE SHOWS THIS EVENT IS RELATED TO A TRENT OF SIMILAR EVENTS WHERE THE GREEN OVERMOLD HANDLES OF TRIATHLON INSTRUMENTATION IS FOUND TO BE STICKY AND DEGRADING AFTER STERILIZATION. THIS IS THE SAME EVENT AS: MFR # 2249697-2011-00340, MFR # 2249697-2011-00341. MFR # 2249697-2011-00342.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PREPARING TRAY FOR UPCOMING SURGERY, INSTRUMENTS WERE FOUND TO BE DAMAGED. ALL 4 OF THESE INSTRUMENTS HAVE TEAL GRIPS AND APPEAR TO BE DISCOLORED AND HAVE GOOEY RESIDUE. STERILE PROCESSING REPORTED NOTHING DIFFERENT DONE TO ITEMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATELLA CALIPER INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA SBZT11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other