BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCORPIO FIXED BPLATE HA SIZE 5

    MDR report key: 3093478 · Received May 6, 2013

    Report

    Report Number
    0002249697-2013-01550
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FOREIGN MATERIAL INVOLVING A SCORPIO BASEPLATE WAS REPORTED. THE EVENT WAS CONFIRMED. NO PATIENT ADVERSE CONSEQUENCES WERE REPORTED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION INDICATES THAT THE FOREIGN MATERIAL APPEARS TO BE SEVERAL SHORT LIGHT COLOURED/WHITE FIBRES. A MATERIAL ANALYSIS HAS BEEN PERFORMED ON THE RETURNED DEBRIS. SAMPLES OF PACKAGING MATERIALS WERE ALSO SENT FOR ANALYSIS TO COMPARE WITH THE RETURNED DEBRIS. MATERIAL ANALYSIS REPORT INDICATES THAT THERE IS NO EVIDENCE TO SUPPORT EITHER PACKAGING MATERIAL BEING THE SOURCE OF THE FOREIGN MATERIAL FOUND ON THE GREEN CARDBOARD SAMPLE. THE SPECTRUM OF THE FOREIGN MATERIAL WAS ALMOST IDENTICAL TO THAT OF THE CARDBOARD WHICH SUGGESTS THAT THE CONTAMINATION MAY BE AN INORGANIC MATERIAL WITH LITTLE OR NO IR RESPONSE. THESE CONCLUSIONS MUST BE CONSIDERED AS TENTATIVE DUE TO THE ADHESIVE TAPE WHICH HAD BEEN APPLIED OVER THE GREEN CARDBOARD SAMPLE WHICH HAD TO BE REMOVED PRIOR TO ANALYSIS. DEVICE HISTORY REVIEW: DHR REVIEW WAS SATISFACTORY. COMPLAINT HISTORY REVIEW: CHR REVIEW DETERMINED THAT THERE WERE NO SIMILAR EVENTS FOR THE LOT. CONCLUSIONS: NC WAS ISSUED TO INVESTIGATE THE ROUTE CAUSE OF THE FOREIGN MATERIAL ON THE SURFACE OF THE BASEPLATE. MATERIAL ANALYSIS WAS COMPLETED ON THE RETURNED FOREIGN MATERIAL HOWEVER IT COULD NOT DEFINITIVELY IDENTIFIED DUE TO CONTAMINATION FROM THE ADHESIVE TAPE AND IT COULD NOT BE LINKED TO PACKAGING FROM THE STRYKER MANUFACTURING PROCESS OR TO ANY OTHER PART OF THE MANUFACTURING PROCESS. THE NC WAS SUBSEQUENTLY CANCELLED.

    Description of Event or Problem · 1

    DURING SURGERY, RIGHT AFTER THE PACKAGE WAS OPENED, SOME WHITE SUBSTANCE WAS FOUND ON THE SURFACE OF THE IMPLANT. THE IMPLANT WAS WASHED THOROUGHLY AND THEN USED.

    Description of Event or Problem · 1

    DURING SURGERY, RIGHT AFTER THE PACKAGE WAS OPENED, SOME WHITE SUBSTANCE WAS FOUND ON THE SURFACE OF THE IMPLANT. THE IMPLANT WAS WASHED THOROUGHLY AND THEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196537 SCORPIO FIXED BPLATE HA SIZE 5 IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other