BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER 2.5 I M PLUG 16MM

    MDR report key: 3233638 · Received July 18, 2013

    Report

    Report Number
    0002249697-2013-02366
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K980843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ANY ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. PRODUCT NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING MISSING BONE PLUG AND STERILE BLISTERS FROM THE PACK INVOLVING AN EXETER BONE PLUG WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THIS EVENT RELATES TO A PACKAGING ISSUE, AND THE COMPONENT WAS NOT IMPLANTED. DEVICE EVALUATION AND RESULTS: A PHOTOGRAPH OF THE EXETER IM PLUG UNIT CARTON WAS PROVIDED. THE PHOTOGRAPH SHOWS THE OPENED UNIT CARTON (WITHOUT SHRINK WRAP) AND THE PATIENT LABELS. DEVICE HISTORY REVIEW: DHR REVIEW WAS SATISFACTORY, INCLUDING LABEL AND UNIT RECONCILIATION THROUGHOUT THE PACKAGING PROCESS. COMPLAINT HISTORY REVIEW: CHR REVIEW CONFIRMED THAT THERE WERE NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. CONCLUSIONS: REVIEW OF THIS CUSTOMER COMPLAINT WITH STERIPACK AND THE RELEVANT SUPPLIER QUALITY ENGINEER WAS PERFORMED. THE INVESTIGATION CONCLUDED THAT THE PROBABILITY OF PACKAGING AN EMPTY BOX AS PART OF THE PLUG PACKAGING PROCESS AT STERIPACK WAS DEEMED TO BE NEGLIGIBLE. THE INVESTIGATION CONCLUDED THAT THE PROCESS CONTROLS, CHECKS AND RECONCILIATIONS THAT OCCUR THROUGHOUT THE PACKAGING PROCESS WOULD PREVENT SUCH AN EVENT FROM OCCURRING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACCOUNT OPENED A EXETER INTRAMEDULLARY PLUG FOR USE AND THE BOX WAS EMPTY. IT WAS REPORTED THAT THERE WAS NO PLUG JUST STICKERS AND IFU.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACCOUNT OPENED A EXETER INTRAMEDULLARY PLUG FOR USE AND THE BOX WAS EMPTY. IT WAS REPORTED THAT THERE WAS NO PLUG JUST STICKERS AND IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334795 EXETER 2.5 I M PLUG 16MM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH L5476

    Patients

    Seq Age Sex Outcome Treatment
    1 Other