BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA BLADE PERF L110 TAN

    MDR report key: 2831412 · Received October 11, 2012

    Report

    Report Number
    8030965-2012-01042
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Report Date
    September 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COORDINATED BY SYNTHES (B)(4). VISUAL INSPECTIONS NOTED THE BLADE IS IN GOOD SHAPE AND FULLY FUNCTIONAL. NO FAULT COULD BE DETECTED AFTER DISMANTLING AND CLEANING OF THE BLADE. THE ITEM WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATION, AS WELL AS THE DEVICE HISTORY RECORD WAS REVIEWED; NO ABNORMAL FINDINGS WERE IDENTIFIED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PROCEDURE, THE PFNA BLADE WOULD NOT LOCK AND TURN. SURGEON REMOVED THE BLADE, ANOTHER PFNA BLADE WAS SELECTED AND THE PROCEDURE WAS COMPLETED. THE SURGERY WAS DELAYED A SMALL AMOUNT OF TIME. NO ADDITIONAL MEDICAL TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFNA BLADE PERF L110 TAN PFNA BLADE KTT SYNTHES GMBH 2774389

    Patients

    Seq Age Sex Outcome Treatment
    1