BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL SIMPLEX CEMENT

    MDR report key: 3864160 · Received June 10, 2014

    Report

    Report Number
    0002249697-2014-02165
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE 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 A PARTIALLY DELAMINATED AMPOULE (B)(4) LID INVOLVING A SURGICAL SIMPLEX CEMENT PACK WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION AND RESULTS: SOME INTERWOVEN LAYERS OF THE (B)(4) LID HAVE SEPARATED FROM THE LID AND ARE STILL ATTACHED TO THE BLISTER SEAL FLANGE UPON OPENING OF THE (B)(4) LID. FOR THE REMAINDER, THERE IS EVIDENCE OF A GOOD SEAL BETWEEN THE (B)(4) LID AND THE BLISTER. DEVICE HISTORY REVIEW: THE TWIN PACK DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE PARTIAL SEPARATION OF INTERWOVEN FIBRES FROM THE (B)(4) LID WAS CAUSED BY A STRONG ADHESIVE SEAL HAVING FORMED BETWEEN THE (B)(4) AND THE BLISTER SEAL FLANGE. THIS PARTIAL SEPARATION DID NOT CONSTITUTE TEARING IN THAT THE (B)(4) LID REMAINED INTACT AS A SINGLE SHEET AND THAT AS SUCH THE STERILE BARRIER AND AMPOULE HAVE REMAINED INTACT. FROM THE STRYKER PERFORMANCE TESTING, AGE TESTING AND IN-PROCESS TESTING THERE IS NO EVIDENCE TO SUGGEST THAT THERE IS AN INHERENT ISSUE WITH THE MATERIALS OR THE DESIGN.

    Description of Event or Problem · 1

    WHEN PACKAGE OF MONOMER WAS OPENED, TYVEK SHEET DIDN'T COME OFF SMOOTHLY AND PRODUCT GOT CONTAMINATION. DR. USED OTHER PRODUCT.

    Description of Event or Problem · 1

    WHEN PACKAGE OF MONOMER WAS OPENED, (B)(4) SHEET DIDN'T COME OFF SMOOTHLY AND PRODUCT GOT CONTAMINATION. DR. USED OTHER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338058 SURGICAL SIMPLEX CEMENT IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH JKU039

    Patients

    Seq Age Sex Outcome Treatment
    1 Other