BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM TI CORTEX SCREW

    MDR report key: 2863556 · Received December 10, 2012

    Report

    Report Number
    2520274-2012-03627
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    July 3, 2010
    Report Date
    July 16, 2010
    Manufacturer
    SYNTHES
    Product Code
    HRS
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. 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 SCREWS WERE BROKEN POST-OP DURING TREATMENT OF A FEMORAL TROCHANTER FRACTURE. IMPLANTATION WAS PERFORMED ON (B)(6) 2010 AND ON (B)(6) TWO SCREWS WERE FOUND BROKEN. THE SURGEON REMOVED ONLY SCREW HEADS AND INSERTED NEW SCREWS IN DIFFERENT DIRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM TI CORTEX SCREW 4.5MM TI CORTEX SCREW HRS SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 4.5MM TI CORTEX SCREW SELF-TAPPING 42MM