BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI END CAP WITH T40 STARDRIVE 0MM EXT F/TI TIBIAL NAILS-EX

    MDR report key: 2973472 · Received February 22, 2013

    Report

    Report Number
    2520274-2013-01127
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, 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 WAS IMPLANTED WITH TIBIAL NAIL, END CAP, AND FIVE SCREWS ON (B)(6) 2012. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR REMOVAL OF HARDWARE DUE TO A NON-UNION. THE SURGEON REVISED THE PATIENT TO A PLATE CONSTRUCT AND BONE GRAFT. DURING THE REVISION SURGERY, WHILE HARVESTING BONE GRAFT WITH THE RIA SYSTEM, THE SURGEON WAS REAMING AND THE TIP OF THE DRIVE SHAFT BROKE OFF. THE DRIVE SHAFT IS IN TWO PIECES. POST X-RAYS TAKEN REVEALED TWO FRAGMENT PIECES; HOWEVER, THE TWO FRAGMENTS COULD NOT BE CONFIRMED AS METAL OR BONE. THE SURGEON USED A BACK UP REAMER TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER INCIDENT. THIS IS 2 OF 8 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78899 TI END CAP WITH T40 STARDRIVE 0MM EXT F/TI TIBIAL NAILS-EX END CAP JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention