BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM PRCSN MTCH HD, 13CM

    MDR report key: 8696360 · Received June 13, 2019

    Report

    Report Number
    0001811755-2019-02012
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    April 24, 2019
    Report Date
    August 27, 2019
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    UDI-DI
    07613327097016
    PMA / PMN Number
    K143540
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE BUR REPORTED INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION. IT WAS REPORTED IN THIS CASE THAT THE SURGEON ACKNOWLEDGED USE OF AN EXPIRED BUR AND WANTED TO ENQUIRE INTO THE RISK ASSOCIATED WITH USING AN EXPIRED PRODUCT. THERE IS NO REPORTED MALFUNCTION OF A STRYKER PRODUCT EVIDENT IN THIS CASE. PHOTO EVIDENCE OF THE BUR PRODUCT LABEL WAS PROVIDED WHERE IT WAS OBSERVED THAT THE BUR WAS EXPIRED. STRYKER INSTRUMENTS APPLIES A THREE (03) YEAR EXPIRY DATE ON PRODUCT CATALOG NUMBER 8450-107-525 2.5MM PRCSN MTCH HD, 13CM AND IS PROVIDED AS A STERILE PRODUCT. THE EXPIRATION DATE IS INDICATED ON THE PRODUCT LABEL AND IS EXPRESSED AS A FOUR-DIGIT YEAR FOLLOWED BY A TWO-DIGIT MONTH AND A TWO-DIGIT DAY. PRECEDING THIS EXPIRATION DATE INFORMATION IS A PARTIALLY FILLED HOURGLASS SYMBOL IDENTIFIER SYMBOLIZING USE-BY DATE, WHICH IS A HARMONIZED SYMBOL PER THE RELEVANT LABELING STANDARD. THE ASSOCIATED EXPANDED CONTENT LABEL #0036-894-000 REV.A CONTAINS THIS SYMBOL DEFINITION. WHILE THE EXPIRATION PERIOD FOR CATALOG NUMBER 8450-107-525 2.5MM PRCSN MTCH HD, 13CM IS LABELED FOR A THREE (03) YEAR EXPIRATION THE PRODUCT PACKAGING STERILE BARRIER INTEGRITY HAS BEEN TESTED FOR FIVE (05) YEARS. STRYKER ARE NOT MEDICAL PROFESSIONALS AND CANNOT MAKE DECISIONS CONCERNING THE HEALTH AND WELFARE OF PATIENTS WHERE AN EXPIRED PRODUCT MAY HAVE BEEN USED DURING A SURGICAL PROCEDURE. THE TREATING PHYSICIAN IS THE ONLY INDIVIDUAL THAT CAN MAKE DECISIONS FOR HIS/HER PATIENT. PRODUCT BEYOND ITS EXPIRY DATE MUST NOT BE USED AS ITS SAFETY AND EFFECTIVENESS CANNOT BE PREDICTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SURGEON USED AN EXPIRED BUR. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE DISCARDED BY CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SURGEON USED AN EXPIRED BUR. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487954 3.0MM PRCSN MTCH HD, 13CM DRILLS, BURRS, TREPHINES & ACCESSORIES HBE STRYKER INSTRUMENTS-KALAMAZOO 15338017 07613327097016

    Patients

    Seq Age Sex Outcome Treatment
    1