BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW LOCKING

    MDR report key: 2864292 · Received December 10, 2012

    Report

    Report Number
    2520274-2012-03764
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 11, 2012
    Report Date
    November 11, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSIONS COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH HINDFOOT ARTHRODESIS CANNULATED NAIL ON AN UNKNOWN DATE. PATIENT FELL AND IT WAS DISCOVERED THE PATIENT BROKE THE TIBIA ABOVE THE NAIL ON (B)(6) 2012. PATIENT WAS RETURNED TO THE OR ON THE SAME DAY WITH SURGEON WASH OUT THE OPEN FRACTURE. THE NEXT DAY ON (B)(6) 2012, PATIENT WAS RETURNED TO O,R., HARDWARE WAS REMOVED. SURGEON ATTEMPTED TO IMPLANT A COMPETITORS NAIL TO PRESERVE THE ANKLE FUSION. THE BEND IN THE NAIL CAUSED MAL REDUCTION OF THE TIBIA FRACTURE AND ATTEMPT WAS ABORTED. SURGEON THEN DECIDED TO USE A 12 HOLE LCP LOW BEND PLATE WHICH WAS IMPLANTED WITH SUCCESSFUL FIXATION AND REDUCTION OF THE FRACTURE. THE PROCEDURE WAS COMPLETED. THIS IS 4 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW LOCKING HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NAIL, LOCKING SCREW, END CAP