BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL, TRI-FLAT T2 FEMUR Ø4,2X340 MM

    MDR report key: 3200849 · Received July 2, 2013

    Report

    Report Number
    0009610622-2013-00372
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DEVIATIONS IN MANUFACTURING WERE NOT FOUND. ADDITIONAL DIMENSIONAL EXAMINATION REVEALED NO DEVIATIONS IN THE RELEVANT UNDAMAGED AREAS OF THE ITEM. AS MECHANICAL PROPERTIES OF THE MATERIAL OF THE DEVICE WERE WITHIN SPECIFIED TOLERANCES WE EXCLUDE MATERIAL FAULTS. THE DRILLING SPIRAL OF THE DRILL WAS COMPLETELY SHEARED OFF. DAMAGED CUTTING EDGES CONFIRMED CONTACT TO HARD OBJECT(S). THE BREAKAGE SURFACE IDENTIFIED A (FORCED) BRITTLE MANNER. ACCORDING TO FOUND DAMAGES THE EVENT WAS CAUSED BY IMPROPER HANDLING. THE EVENT WAS NOT CAUSED BY A DEFICIENCY OF THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2013 DURING T2SCN SURGERY, WHEN THE SURGEON DRILLED THE SCREW HOLE AT POSITION 2, THE DRILL BROKE. THE BROKEN TIP OF THE DRILL WAS REMOVED FROM THE PATIENT BODY. THE SURGEON INSERTED THE SCREW AND FINISHED THE SURGERY.

    Description of Event or Problem · 1

    ON (B)(6) 2013 DURING T2SCN SURGERY, WHEN THE SURGEON DRILLED THE SCREW HOLE AT POSITION 2, THE DRILL BROKE. THE BROKEN TIP OF THE DRILL WAS REMOVED FROM THE PATIENT BODY. THE SURGEON INSERTED THE SCREW AND FINISHED THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303208 DRILL, TRI-FLAT T2 FEMUR Ø4,2X340 MM INSTRUMENT HSZ STRYKER OSTEOSYNTHESIS-KIEL K430230

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Other