BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM CORTEX SCREW SELF-TAPPING 26MM

    MDR report key: 2960334 · Received February 14, 2013

    Report

    Report Number
    1719045-2013-00311
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 18, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WITH PILON FRACTURE WAS TREATED WITH A TEMPORARY EXFIX ON AN UNKNOWN DATE. PATIENT RETURNED TO THE OR ON (B)(6) 2012 FOR SCHEDULED ORIF WITH PLATES AND SCREWS. DURING THE PROCEDURE THE SURGEON WAS TURNING THE SCREWDRIVER AND FIRST IT BROKE INTO TWO PIECES, THEN THE TWO PIECES SHATTERED INTO FRAGMENTS. THE FRAGMENTS FELL INTO THE PATIENT WOUND. THE SURGEON FLUSHED AND SUCTIONED THE WOUND. THE SURGEON PERFORMED A SECOND FLUSH AND SUCTION. ON (B)(6) 2013, IT WAS REPORTED THE PATIENT HAS AN INFECTION IN THE SURGICAL SITE; THERE IS NO INFORMATION ON TREATMENT PROVIDED. THIS IS 11 OF 16 REPORTS FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64493 3.5MM CORTEX SCREW SELF-TAPPING 26MM CORTEX SCREW SELF-TAPPING HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention