BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX ABC CE MARK 1 PCK

    MDR report key: 5344984 · Received January 5, 2016

    Report

    Report Number
    0002249697-2016-00013
    Event Type
    Injury
    Date Received
    January 5, 2016
    Date of Event
    December 11, 2015
    Report Date
    December 11, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING THE BASE OF THE AMPOULE BREAKING INTO SMALL PIECES WHILE OPENING A SIMPLEX LIQUID AMPOULE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: THE FRACTURED AMPOULE WAS RETURNED FOR EVALUATION. THE FRACTURED AMPOULE PIECES WERE RETURNED IN A SEALED CONTAINER AS THERE WAS ALSO BLOOD CONTAMINATION ON THE AMPOULE DUE TO THE CUT THE NURSE SUSTAINED. THE AMPOULE NIB WAS BROKEN CLEANLY OFF. THE BASE OF THE AMPOULE (APPROXIMATELY HALF THE AMPOULE) HAD BROKEN INTO SEVERAL PIECES. SIX RETAIN AMPOULES FROM THE SAME SIMPLEX LIQUID LOT WERE ALSO VISUALLY INSPECTED. VISUAL INSPECTION INDICATED THAT THE AMPOULES MET VISUAL INSPECTION CRITERIA AND THAT THE PLASTIC CRACKERS WERE PRESENT ON THE AMPOULES. FUNCTIONAL TESTING WAS ALSO PERFORMED ON THE SIX RETAIN AMPOULES. THE PURPOSE OF THE TEST WAS TO VERIFY THE CORRECT OPENING OF THE AMPOULES, THAT THE BREAK WAS CLEAN UPON OPENING OR SNAPPING OFF THE TIP OF THE AMPOULE. OPENING OF THE AMPOULES: CLEAN BREAKS WERE OBSERVED WITH ALL 6 AMPOULES. THERE WAS NO EVIDENCE OF VISIBLE FISSURES PRESENT ON THE AMPOULES NECK OR EXCESSIVE FRAGMENTS OF GLASS GENERATED UNDER THE BREAKAGE. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. DEVICE HISTORY REVIEW: REVIEW OF THE BMR WAS SATISFACTORY. COMPLAINT HISTORY REVIEW: CHR CONFIRMED THAT THERE WERE NO OTHER SIMILAR EVENTS REPORTED FOR THE LOT. CONCLUSIONS: THE FRACTURED AMPOULE WAS RETURNED FOR EVALUATION. THE FRACTURED AMPOULE PIECES WERE RETURNED IN A SEALED CONTAINER AS THERE WAS ALSO BLOOD CONTAMINATION ON THE AMPOULE DUE TO THE CUT THE NURSE SUSTAINED. THE AMPOULE NIB WAS BROKEN CLEANLY OFF. THE BASE OF THE AMPOULE (APPROXIMATELY HALF THE AMPOULE) HAD BROKEN INTO SEVERAL PIECES. SIX RETAIN AMPOULES FROM THE SAME SIMPLEX LIQUID LOT WERE ALSO VISUALLY INSPECTED. VISUAL INSPECTION INDICATED THAT THE AMPOULES MET VISUAL INSPECTION CRITERIA AND THAT THE PLASTIC CRACKERS WERE PRESENT ON THE AMPOULES. FUNCTIONAL TESTING WAS ALSO PERFORMED ON THE SIX RETAIN AMPOULES. THE PURPOSE OF THE TEST WAS TO VERIFY THE CORRECT OPENING OF THE AMPOULES, THAT THE BREAK WAS CLEAN UPON OPENING OR SNAPPING OFF THE TIP OF THE AMPOULE. OPENING OF THE AMPOULES: CLEAN BREAKS WERE OBSERVED WITH ALL 6 AMPOULES. THERE WAS NO EVIDENCE OF VISIBLE FISSURES PRESENT ON THE AMPOULES NECK OR EXCESSIVE FRAGMENTS OF GLASS GENERATED UNDER THE BREAKAGE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    GLASS AMPOULE OF LIQUID MONOMER SHATTERED WHEN TOP WAS BEING SNAPPED OFF. SCRUB NURSE CUT HAND. BACK TABLE CONTAMINATED WITH BLOOD AND LIQUID MONOMER. SCRUB NURSE WAS RELIEVED BY ANOTHER TEAM MEMBER, BACK TABLE RESET FOR CEMENT MIXING WITH REPLACEMENT DRAPES / PRODUCTS, AND PROCEDURE CONTINUED.

    Description of Event or Problem · 1

    GLASS AMPOULE OF LIQUID MONOMER SHATTERED WHEN TOP WAS BEING SNAPPED OFF. SCRUB NURSE CUT HAND. BACK TABLE CONTAMINATED WITH BLOOD AND LIQUID MONOMER. SCRUB NURSE WAS RELIEVED BY ANOTHER TEAM MEMBER, BACK TABLE RESET FOR CEMENT MIXING WITH REPLACEMENT DRAPES / PRODUCTS, AND PROCEDURE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4837 SIMPLEX ABC CE MARK 1 PCK BONE CEMENT LOD STRYKER ORTHOPAEDICS-MAHWAH BHW031

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention