BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM CARBIDE MATCH HEAD

    MDR report key: 7177847 · Received January 10, 2018

    Report

    Report Number
    0001811755-2018-00033
    Event Type
    Malfunction
    Date Received
    January 10, 2018
    Date of Event
    December 15, 2017
    Report Date
    March 1, 2018
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    UDI-DI
    7613327294989
    PMA / PMN Number
    K143320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. AWAITING DEVICE RETURN TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS INDICATE THAT THE HOLES IN THE PACKAGING WERE CREATED BY INTERACTION OF THE DEVICE AND THE PACKAGING, THE PRODUCT HAS BEEN PACKAGED IN IT'S QUALIFIED CONFIGURATION AND THAT THE FORCE TO CREATE THE DAMAGE OBSERVED ON THE PACKAGING IS MANY TIMES IN EXCESS OF WHAT WOULD BE EXPECTED IN THE DISTRIBUTION ENVIRONMENT. IT IS LIKELY THAT AN UNEXPECTED HIGH FORCE EVENT OCCURRED. THE LABEL, #5820-107-728 REV. NONE, INDICATES BY WAY OF AN EXPANDABLE LABEL #0036-902-000 REV. B ICON "DO NOT USE IF PACKAGE IS DAMAGED". THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POTENTIAL STERILITY BREACH ON THE PACKAGING OF TWO DEVICES. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. THIS REPORT IS FOR THE FIRST DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POTENTIAL STERILITY BREACH ON THE PACKAGING OF TWO DEVICES. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. THIS REPORT IS FOR THE FIRST DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22186 3.0MM CARBIDE MATCH HEAD DRILLS, BURRS, TREPHINES & ACCESSORIES HBE STRYKER INSTRUMENTS-KALAMAZOO 17335027 7613327294989

    Patients

    Seq Age Sex Outcome Treatment
    1