BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/35MM

    MDR report key: 2822327 · Received November 7, 2012

    Report

    Report Number
    2520274-2012-02962
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 10, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS IMPLANTED WITH TWO 4.0MM CANCELLOUS BONE SCREWS AND TWO WASHERS 7.0MM AT THE MEDIAL MALLEOLUS FOR AN ORIF BIMALLEOLAR ANKLE FRACTURE ON AN UNKNOWN DATE. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. PATIENT COMPLAINED OF PAIN. SURGEON REMOVED TWO SCREWS AND TWO WASHERS. PATIENT WAS NOT REVISED WITH ANY ADDITIONAL HARDWARE AS THE PATIENT'S FRACTURE WAS UNITED. PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENTS PREOP STATUS WAS PAINFUL HARDWARE AND PATIENT'S POSTOP STATUS IS UNKNOWN AT THIS TIME. PATIENT ALSO HAS TUBULAR PLATE, CORTEX SCREWS, AND LOCKING SCREWS IMPLANTED IN THE FIBULA, ON THE LATERAL SIDE OF THE ANKLE. NO REPORTED COMPLAINT AGAINST THE PLATE AND SCREWS IMPLANTED IN THE PATIENT'S FIBULA. THIS IS 2 OF 4 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/35MM SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention SCREW, WASHERS