BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM F/IM NAILS-STER

    MDR report key: 3360989 · Received September 20, 2013

    Report

    Report Number
    2520274-2013-06459
    Event Type
    Injury
    Date Received
    September 20, 2013
    Report Date
    August 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    PMA / PMN Number
    K103002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CODE AND 510K NUMBER: HWC-K000089. 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

    CUSTOMER FACILITY REPORTED THAT PATIENT WAS ORIGINALLY IMPLANTED WITH A TIBIAL NAIL AND THREE SCREWS TO TREAT A TIBIAL FRACTURE ON (B)(6) 2013. IT WAS REPORTED THE SCREW WAS NOT STATICALLY LOCKED TO ALLOW FOR MOVEMENT AND TO ALLOW THE FRACTURE TO COLLAPSE. THIS ULTIMATELY CAUSED THE TIBIAL NAIL TO MOVE AND PREVENTED THE PATIENT FROM BEING ABLE TO STRAIGHTEN HER LEG. REVISION SURGERY WAS PERFORMED ON (B)(6) 2013 AND THE TIBIAL NAIL WAS RE-IMPLANTED, THE THREE ORIGINAL SCREWS WERE EXPLANTED AND REPLACED WITH THREE DISTAL LOCKING SCREWS. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR A 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM F/IM NAILS-STER. THIS IS 4 OF 4 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476699 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM F/IM NAILS-STER HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR