BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIV-FEMNAIL Ø10 L380 SST

    MDR report key: 2862512 · Received December 10, 2012

    Report

    Report Number
    2520274-2012-03642
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    July 30, 2010
    Manufacturer
    SYNTHES
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    (B)(6) COMPLAINT HANDLING UNIT REPORTED A BROKEN UNI FEMNAIL. THE RIGHT FEMUR BONE FRACTURE WAS STABILIZED BY MEANS OF UNREAMED FEMORAL NAIL, DATE OF NAIL BREAKAGE UNKNOWN. REVISION SURGERY PERFORMED ON (B)(6) 2010, PSEUDOARTHROSIS AND METALLOSIS IN THE SPINAL CANAL WERE NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIV-FEMNAIL Ø10 L380 SST JDS SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNIV-FEMNAIL Ø10 L380 SST