BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3200838 · Received July 2, 2013

    Report

    Report Number
    0009610622-2013-00374
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF THE DRILL WAS BROKEN. ACCORDING TO THE SR, DURING T2SCN SURGERY THE DRILL WAS DAMAGED IN CONTACT WITH THE FEMORAL COMPONENT.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF THE DRILL WAS BROKEN. ACCORDING TO THE SR, DURING T2SCN SURGERY THE DRILL WAS DAMAGED IN CONTACT WITH THE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303340 DRILL, TRI-FLAT T2 FEMUR Ø4,2X340 MM INSTRUMENT HSZ STRYKER OSTEOSYNTHESIS-KIEL K242646

    Patients

    Seq Age Sex Outcome Treatment
    1 Other