BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01657

    MDR report key: 3022249 · Received March 26, 2013

    Report

    Report Number
    2520274-2013-01657
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    FZX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT IS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2013, A SYNREAM HEAD BURST INTO PIECES DURING REAMING OF A TIBIAL CANAL. THIS LEFT SHARDS OF THE REAMER HEAD STUCK IN THE CANAL. THE SURGEON WAS UNABLE TO CONTINUE REAMING AND INSERT A TIBIAL NAIL, SO HE USED AN EXTERNAL FIXATOR TO MANAGE THE FRACTURE INSTEAD. IT IS REPORTED THAT THIS INCIDENT ADDED CONSIDERABLE TIME TO THE CASE, ABOUT ONE TO ONE AND A HALF HOURS. IT IS ALSO REPORTED THAT IT WAS UNCERTAIN IF THE GUIDE WIRE THAT WAS BEING USED WAS A SYNTHES GUIDE WIRE. THIS REPORT IS FOR AN UNKNOWN GUIDE WIRE. THIS IS 4 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124250 FZX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention