BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL TIP EXTRACTOR. INCLUDES

    MDR report key: 3973508 · Received August 1, 2014

    Report

    Report Number
    0002249697-2014-02973
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 15, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MATERIAL ANALYSIS INDICATED THE DEVICE FRACTURED DUE TO OVERLOAD. THE INVESTIGATION DETERMINED THE LIKELY ROOT CAUSE OF THE EVENT TO BE BACK IMPACTION OF THE KNOB WHICH OVERLOADED THE COMPONENT AND RESULTED IN FRACTURE. THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. VISUAL INSPECTION: THE RETURNED DEVICE IS IN USED CONDITION WITH MINOR DAMAGES CONSISTENT WITH NORMAL USE. THE KNOB IS FRACTURED FROM THE PROXIMAL END OF THE DEVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING THE REVISION SURGERY OF OMNIFLEX HIP, DISTAL TIP WAS REMAINED IN THE FEMORAL CANAL. THEN THE SURGEON TRIED TO EXTRACT THE DISTAL TIP WITH THE TIP REMOVER, THE DISTAL PART OF REMOVER WAS BROKEN.

    Description of Event or Problem · 1

    DURING THE REVISION SURGERY OF OMNIFLEX HIP, DISTAL TIP WAS REMAINED IN THE FEMORAL CANAL. THEN THE SURGEON TRIED TO EXTRACT THE DISTAL TIP WITH THE TIP REMOVER, THE DISTAL PART OF REMOVER WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450970 DISTAL TIP EXTRACTOR. INCLUDES INSTRUMENT HWB STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other