BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-05321

    MDR report key: 3324890 · Received September 4, 2013

    Report

    Report Number
    2520274-2013-05321
    Event Type
    Malfunction
    Date Received
    September 4, 2013
    Report Date
    August 9, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR 2 UNKNOWN PFNA NAILS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. 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

    JOURNAL ARTICLE RECEIVED: THE NEW PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) IN DAILY PRACTICE: RESULTS OF A MULTICENTRE CLINICAL STUDY, INJURY, 2008: 39: 932-939. AUTHORS: R. KI. J. SIMMERMACHER, J. LJUNGQVIST, H. BAIL, T. HOCKERTZ, A. J. H. VOCHTELOO, U. OCHS, CHR.V.D. WERKEN. STUDY WAS COMPRISED OF 313 PATIENTS WITH 315 UNSTABLE TROCHANTERIC FRACTURES ALL TREATED WITH PFNA. THE MEAN AGE WAS 80.6 YEARS, 77 PERCENT WERE FEMALE. 299 PATIENTS HAD A SINGLE ISOLATED FRACTURE, 53 PERCENT WERE ON THE LEFT AND ALL WERE OF TRAUMATIC ORIGIN. EIGHTY-TWO PERCENT WERE 31.A.2 FRACTURES AND 18 PERCENT WERE 31.A.3 FRACTURES, ALL WERE CLOSED. NINETY-EIGHT PERCENT OF THE FRACTURES WERE UNITED, THE MAJORITY (92 PERCENT) WERE WITHIN 6 MONTHS. THERE WAS A TOTAL OF 165 ADVERSE EVENTS. ONE HUNDRED SEVENTEEN WERE NOT IMPLANT RELATED. FORTY-SIX EVENTS WERE OPERATION OR IMPLANT RELATED RESULTING IN 28 UNPLANNED REOPERATIONS. THIS REPORT IS FOR TWO INSTANCES OF BLADE LOOSENING, ONE WITHIN 6 MONTHS. OUTCOME OF THESE TWO INCIDENTS IS UNKNOWN. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439926 HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1