BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEK 3" 19 GAUGE STRAIGHT

    MDR report key: 2218361 · Received August 11, 2011

    Report

    Report Number
    2648666-2011-00188
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 15, 2011
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    HRX
    PMA / PMN Number
    K032472
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOUND THAT THE AUGER BROKE NEAR PROXIMAL END OF THE DEVICE. THE MOST PROBABLE CAUSE WAS IDENTIFIED AS A BENT OR BROKEN SUGAR PRODUCED BY A BENT OR CURVED CANNULA, INDUCED DURING THE PROCEDURE. THIS CAUSES FRICTION AND VIBRATION BETWEEN THE CANNULA AND AUGER, CONSEQUENTLY, THE FRICTION BETWEEN THE CANNULA AND AUGER HEATS UP THE PROBE MATERIAL AND EVENTUALLY CAUSES THE AUGER BREAKAGE. THEREFORE, THE BROKEN AUGER CLAIMED CONDITION WAS CONFIRMED. THE INSTRUCTIONS FOR USE PROVIDED WITH THE PRODUCT CONTAINED THE FOLLOWING WARNINGS: NEVER BEND OR STRAIGHTEN THE PREFERRED INTRODUCER CANNULA. FAILURE TO COMPLY MAY RESULT IN PT INJURY; AND: DO NOT APPLY EXCESSIVE FORCE TO THE PROBE IN ANY DIRECTION DURING THE PROCEDURE TO AVOID DAMAGING ANATOMICAL STRUCTURES OR BREAKING THE DEVICE. FAILURE TO COMPLY MAY RESULT IN PT INJURY.

    Description of Event or Problem · 1

    DURING THE SECOND PASS OF A CERVICAL DISCECTOMY PROCEDURE, APPROXIMATELY 1.0 CM OF THE AUGER SHAFT BROKE AND REMAINED IN THE PT. BACK UP EQUIPMENT WAS NOT AVAILABLE. A SECOND PROCEDURE OCCURRED 3 DAYS LATER TO REMOVE THE NEEDLE THAT REMAINED IN THE PT. ANTIBIOTICS WERE PRESCRIBED. THE SECOND PROCEDURE WAS ALSO A COMPLETION OF THE ORIGINAL DISCECTOMY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEK 3" 19 GAUGE STRAIGHT HRX STRYKER INSTRUMENTS PUERTO RICO 11063012

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R