BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIST DRILL, DIAM.1.9X94MM, WL 27MM, STRYKER SHAFT END, STERILE PACKED

    MDR report key: 3914162 · Received July 3, 2014

    Report

    Report Number
    0008010177-2014-00165
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 10, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    HBE
    PMA / PMN Number
    K070876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT THE DRILL MADE AN ECCENTRIC ROTATION COULD NOT BE CONFIRMED. WITHIN THE VISUAL INSPECTION IT WAS DETERMINED THAT THE DRILL HELIX SHOWS NO MACROSCOPICALLY VISIBLE DEFORMATION. AT THE COUPLING AREA A PRESSURE MARK IS VISIBLE MOST LIKELY RESULTING FROM THE ASSEMBLING WITH A THREE JAW DRILL CHUCK INSTEAD OF A J-NOTCH ADAPTER. FURTHERMORE THE CUTTING EDGE OF THE DRILL SHOWS MICROSCOPICALLY VISIBLE PLASTIC DEFORMATIONS IN COUNTER-DRILLING DIRECTION CAUSED BY IMPACTS / COLLISIONS WITH A HARD MATERIAL (NO BONE). SUBSEQUENTLY WITHIN FUNCTIONAL INSPECTION THE DEVICE WAS ASSEMBLED WITH THE RELATED J-NOTCH ADAPTER. THE ROTATION FUNCTION WAS NOT AFFECTED AND A CORRECT CONCENTRIC RUNNING WAS DETERMINED. MOREOVER THE ROTATION FUNCTION WAS CHECKED WITH A PRECISE BOX COLUMN DRILL. ALSO IN THIS CASE THE CONCENTRIC RUNNING WAS FOUND TO BE CORRECT. BASED ON INVESTIGATION THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. MOST LIKELY THE DRILL WAS NOT CONCENTRICALLY ASSEMBLED WITH A THREE JAW DRILL CHUCK. THIS CONSEQUENTLY CAUSED AN ECCENTRIC ROTATION AS NOTICED BY THE SURGEON. INDICATIONS FOR MATERIAL, MANUFACTURING OR DESIGN RELATED ISSUES COULD NOT BE FOUND IN THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A SURGERY, THE DRILL MADE AN ECCENTRIC ROTATION. THE SURGEON USED SPARE DRILL INSTEAD (WITH SAME POWER DRIVER).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A SURGERY, THE DRILL MADE AN ECCENTRIC ROTATION. THE SURGEON USED SPARE DRILL INSTEAD (WITH SAME POWER DRIVER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391905 TWIST DRILL, DIAM.1.9X94MM, WL 27MM, STRYKER SHAFT END, STERILE PACKED INSTRUMENT HBE STRYKER LEIBINGER FREIBURG 1000074249

    Patients

    Seq Age Sex Outcome Treatment
    1