BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL MEDIUM STRAIGHT ATTACHMENT

    MDR report key: 2140370 · Received June 17, 2011

    Report

    Report Number
    1811755-2011-02236
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 28, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBABLE CAUSE OF THE BUR BREAKING WAS ATTRIBUTED TO DEBRIS IN THE BUR PILOT WHICH CAUSED THE WEDGE COLLET TO FAIL TO OPEN AND RELEASE THE BUR. THE MICRO DRILL MEDIUM STRAIGHT ATTACHMENT IS NOT A REPAIRABLE DEVICE; IT WAS DISCARDED AFTER THE QUALITY INVESTIGATION WAS COMPLETE.

    Description of Event or Problem · 1

    THE MICRO DRILL MEDIUM STRAIGHT ATTACHMENT WAS SENT IN FOR EVAL BECAUSE IT HAS A BROKEN BUR IN IT. THE EVENT WAS NOTICED PRIOR TO A PROCEDURE; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO DRILL MEDIUM STRAIGHT ATTACHMENT ERL STRYKER INSTRUMENTS KALAMAZOO 10130

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK