BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINS/WIRES

    MDR report key: 2872423 · Received December 13, 2012

    Report

    Report Number
    2520274-2012-03937
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    DZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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

    SURGEON INSERTED SCREW IN THE MEDIAL MALLEOLUS USING A 1.6 MM TROCAR AND PLACED 2 GUIDE WIRES IN PATIENT. SURGEON MEASURED AND USED A 3.2 DRILL BIT; WHEN THE DRILL BIT WAS REMOVED, THE 1.6 GUIDE WIRE CAME OUT IN THE DRILL BIT. THE SURGEON HAD TO DRILL ANOTHER HOLE AND THE TECH ATTEMPTED TO REMOVE THE GUIDE WIRE OUT OF THE DRILL BIT SO THAT IT COULD BE RE USED. SHE TRIED BOTH A NEEDLE DRIVER AND PLIERS UNSUCCESSFULLY. SHE USED THE TROCAR TO TRY TO PUSH IT OUT AND STUCK HERSELF WITH IT IN THE PINKIE FINGER. SHE BROKE SCRUB AND FOLLOWED FACILITY PROTOCOL FOR HER INJURY. THE PHYSICIAN USED ANOTHER DRILL BIT IN THE SET TO COMPLETE THE PROCEDURE. THIS IS 3 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINS/WIRES DZK SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TROCAR, DRILL BIT, PIN, WIRE