BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ALIGNMENT HANDLE

    MDR report key: 3910410 · Received July 2, 2014

    Report

    Report Number
    0002249697-2014-02508
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN 3 OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT VISUAL INSPECTION: THE HANDLE IS WORN AN DEGRADED. THE DAMAGED DEVICE WAS DISCOVERED DURING INSPECTION; THERE WAS NO SURGICAL PROCEDURE ASSOCIATED WITH THE REPORTED EVENT. THIS EVENT MEETS THE DEFINITION OF PREVENTIVE MAINTENANCE; NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    I WAS COVERING A CASE FOR RJ AND SPD PERSONAL SHOWED ME A PART WITH GREEN COATING COMING OFF AFTER WASH CYCLE OF REPROCESSING.

    Description of Event or Problem · 1

    I WAS COVERING A CASE FOR (B)(6) PERSONAL SHOWED ME A PART WITH GREEN COATING COMING OFF AFTER WASH CYCLE OF REPROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388279 TIBIAL ALIGNMENT HANDLE INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH NYL09

    Patients

    Seq Age Sex Outcome Treatment
    1 Other