BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2014-00723

    MDR report key: 3638122 · Received February 20, 2014

    Report

    Report Number
    2520274-2014-00723
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Report Date
    January 23, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. CLINICAL BIOMECHANICS 24 (2009) 53-58. DEVICE IS AN UNKNOWN DHS, QUANTITY 1. CANNOT BE DETERMINED WITHOUT A PART NUMBER. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. PLACEHOLDER.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: QUANTIFICATION OF CANCELLOUS BONE-COMPACTION DUE TO DHS® BLADE INSERTION AND INFLUENCE UPON CUT-OUT RESISTANCE; MARKUS WINDOLF, RAPHAEL MUTHS, VOLKER BRAUNSTEIN, BOYKO GUEORGUIER, MARKUS HANNI, KARSTEN SCHWEIGER; CLINICAL BIOMECHANICS 24 (2009) 53-58. COMPACTION OF CANCELLOUS BONE IS BELIEVED TO PREVENT CUT-OUT. THIS IN VITRO STUDY QUANTIFIED THE COMPACTION IN THE FEMORAL HEAD DUE TO INSERTION OF A DYNAMIC HIP SCREW-BLADE WITH AND WITHOUT PREDRILLING AND INVESTIGATED THE RESULTING IMPLANT ANCHORAGE UNDER CYCLIC LOADING. EIGHT PAIRS OF HUMAN CADAVERIC FEMORAL HEADS WERE INSTRUMENTED WITH A DYNAMIC HIP SCREW BLADE MADE OF POLYETHERETHERKETONE. PAIRWISE INSTRUMENTATION WAS PERFORMED EITHER WITH OR WITHOUT PREDRILLING THE SPECIMENS. CT SCANNING WAS PERFORMED BEFORE AND AFTER IMPLANTATION, TO MEASURE BONE COMPACTION. SUBSEQUENTLY THE IMPLANT WAS REMOVED AND A THIRD SCAN WAS PERFORMED TO ANALYZE THE RELAXATION OF THE BONE STRUCTURE. COMMERCIAL IMPLANTS WERE REINSERTED AND THE SPECIMENS WERE CYCLICALLY LOADED UNTIL ONSET OF CUT-OUT OCCURRED. THE BONE-IMPLANT INTERFACE WAS MONITORED BY MEANS OF FLUOROSCOPIC IMAGING THROUGHOUT THE EXPERIMENT. PAIRED T-TESTS WERE PERFORMED TO IDENTIFY DIFFERENCES REGARDING COMPACTION, RELAXATION AND CYCLES TO FAILURE. BONE DENSITY IN THE SURROUNDING OF THE IMPLANT INCREASED ABOUT 30 PERCENT FOR THE NON-PREDRILLED AND 20 PERCENT FOR THE PREDRILLED GROUP WHEN INSERTING THE IMPLANT. AFTER IMPLANT REMOVAL THE PREDRILLED SPECIMENS FULLY RELAXED; THE NON-PREDRILLED GROUP SHOWED ABOUT 10 PERCENT PLASTIC DEFORMATION. NO DIFFERENCES WERE FOUND REGARDING CYCLES TO FAILURE. SIGNIFICANT BONE-COMPACTION DUE TO BLADE INSERTION WAS VERIFIED. EVEN THOUGH COMPACTION WAS LOWER WHEN PREDRILLING THE SPECIMENS, MAINLY ELASTIC DEFORMATION WAS PRESENT, WHICH IS BELIEVED TO PRIMARILY ENHANCE THE IMPLANT ANCHORAGE. CYCLIC LOADING TESTS CONFIRMED THIS THESIS. THE IMPORTANCE OF THE IMPLANTATION TECHNIQUE WITH REGARD TO PREDRILLING IS THEREFORE DECREASED. IMPLANT CUT-OUT, WHICH DESCRIBES A LOSS OF IMPLANT ANCHORAGE IN THE CANCELLOUS BONE, OCCURS IN 1¿6 PERCENT OF THE CASES WHEN USING SCREW BASED FIXATION LIKE THE DYNAMIC HIP SCREW (DHS) OR THE PROXIMAL FEMUR NAIL (PFN). THE DHS BLADE (SYNTHES INC., BETTLACH, SWITZERLAND) WAS INTRODUCED RECENTLY AS ADVANCEMENT OF THE CONVENTIONAL DHS FOR TREATMENT OF OSTEOPOROTIC FRACTURES. WHEN CYCLICALLY LOADING THE CONSTRUCTS, ALL SPECIMENS FAILED DUE TO MIGRATION OF THE HEAD IN DIRECTION OF THE IMPLANT AXIS. A BIOMECHANICAL COMPARISON OF CONVENTIONAL DHS AND DHS BLADE REFLECTED 100 PERCENT CUT-OUTS OF THE TESTED DHS SPECIMENS DUE TO EXTREME CONDITIONS OF THE UTILIZED MODEL. IN CONTRAST, ONLY HALF OF THE DHS BLADE SAMPLES FAILED DUE TO CUT-OUT. THIS REPORT IS ON AN UNKNOWN DHS. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107476 KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1