BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFSET ADAPTER 4MM

    MDR report key: 3092984 · Received May 3, 2013

    Report

    Report Number
    0002249697-2013-01538
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 11, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K060360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PACKAGING DAMAGE INVOLVING AN OFFSET ADAPTER WAS REPORTED. THE EVENT WAS CONFIRMED. VISUAL INSPECTION CONFIRMED THE REPORTED EVENT. IT APPEARS THAT THE BOX WAS EXCESSIVELY HANDLED TO THE EXTENT THAT THE CARTON COLLAPSED AND THE BLISTERS BURST. A DEVICE HISTORY REVIEW CONFIRMED THAT THIS BATCH WAS MANUFACTURED AND ACCEPTED INTO FINISHED GOODS WITH NO REPORTED DISCREPANCIES. A COMPLAINT HISTORY REVIEW CONFIRMED NO SIMILAR EVENTS FOR THE REPORTED LOT. THE INVESTIGATION CONCLUDED THAT THE RETURNED CARTON IS SEVERELY DAMAGED, FALLING APART AND COMPRESSED ALONG THE ENTIRE LENGTH OF THE CARTON. THE OUTER BLISTER IS COMPRESSED AND THE INNER BLISTER WITHIN IS SHATTERED. THIS CARTON WAS SUBJECTED TO EXCESSIVE HANDLING TO THE EXTENT THAT THE CARTON AND BLISTERS WITHIN HAVE BROKEN DOWN. IT IS NOTED THAT THE DEVICE WAS ATTEMPTED TO BE IMPLANTED AFTER FOUR YEARS ON THE SHELF AND WAS PART OF A LOAN KIT

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    OPENED BOX AND THE INSIDE OF THE BOX CONTAINING THE IMPLANT WAS BROKEN AND THE IMPLANT FELL TO THE FLOOR. OPENED ANOTHER BOX (SAME IMPLANT) AND PLASTIC WAS DAMAGED TOO, BUT THE DOCTOR DEEMED IT STERILE AND WAS IMPLANTED.

    Description of Event or Problem · 1

    OPENED BOX AND THE INSIDE OF THE BOX CONTAINING THE IMPLANT WAS BROKEN AND THE IMPLANT FELL TO THE FLOOR. OPENED ANOTHER BOX (SAME IMPLANT) AND PLASTIC WAS DAMAGED TOO, BUT THE DOCTOR DEEMED IT STERILE AND WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195284 OFFSET ADAPTER 4MM IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH LAXJO

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other