BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 3910803 · Received July 2, 2014

    Report

    Report Number
    0002249697-2014-02528
    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
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PIN HOLES IN AN INNER POUCH INVOLVING SIMPLEX CEMENT POWDER WAS REPORTED. THE EVENT WAS CONFIRMED. VISUAL INSPECTION CONFIRMS THE PRESENCE OF A PIN HOLE IN THE BOTTOM OF THE INNER POUCH CONTAINING THE POWDER. SOME POWDER WAS VISIBLE IN THE OUTER POUCH IN THE LOCATION OF THE HOLE IN THE INNER POUCH. BMR REVIEW FOR THE REPORTED LOT WAS SATISFACTORY. CHR REVIEW FOR THE REPORTED LOT CONFIRMED THAT THERE WERE NO SIMILAR EVENTS REPORTED FOR THE LOT. CONCLUSIONS: THE INVESTIGATION COMPLETED BY THE SIMPLEX MANUFACTURING CELL CONCLUDED THAT THE INNER SACHET/POUCH DOES NOT COME INTO CONTACT WITH EQUIPMENT WHICH COULD RESULT IN THIS DEFECT TYPE. SACHET/POUCHES ARE VISUALLY INSPECTED PRE-STERILISATION (100%), POST STERILISATION (AQL SAMPLE) AND AQL SAMPLE OF FG UNITS PRIOR TO RELEASE. AQL SAMPLE OF INNER AND OITER POUCHES ARE BLUE DYE TESTED AND ALSO BURST TESTED TO DEFINED ACCEPTANCE SPECIFICATIONS. OUTER POUCH WAS NOT DAMAGED, RULING OUT FG PACKAGING PROCESS. THE DAMAGE TO THE INNER POUCH IS CONSISTENT WITH A SHARP INSTRUMENT/OBJECT BEING USED TO REMOVE THE INNER POUCH FROM THE OUTER POUCH. NO FURTHER INVESTIGATION FOR THIS EVENT IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOME AVAILABLE, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POLYMER POUCH HAD PIN HOLE THOUGH CUSTOMER DIDN'T GIVE ANY DAMAGE TO THE PACKAGE. ANOTHER POUCH DIDN'T HAVE HOLE AND DR. USED IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POLYMER POUCH HAD PIN HOLE THOUGH CUSTOMER DIDN'T GIVE ANY DAMAGE TO THE PACKAGE. ANOTHER POUCH DIDN'T HAVE HOLE AND DR. USED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387238 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH JLU042

    Patients

    Seq Age Sex Outcome Treatment
    1 Other