BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTION BUR GUARD

    MDR report key: 3972994 · Received August 1, 2014

    Report

    Report Number
    0001811755-2014-02755
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 8, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    K961970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CRACK IN THE DEVICE WAS NOT ABLE TO BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    FOLLOWING AN IMPACTION REMOVAL SURGERY AT THE USER FACILITY IT WAS NOTED THAT THE IMPACTION BUR GUARD WAS CRACKED. THE PROCEDURE HAD ALREADY BEEN COMPLETED SUCCESSFULLY WITH NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    FOLLOWING AN IMPACTION REMOVAL SURGERY AT THE USER FACILITY, IT WAS NOTED THAT THE IMPACTION BUR GUARD WAS CRACKED. THE PROCEDURE HAD ALREADY BEEN COMPLETED SUCCESSFULLY WITH NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450023 IMPACTION BUR GUARD INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1