BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.1MM THREADED GUIDE WIRE 150MM

    MDR report key: 3101373 · Received May 9, 2013

    Report

    Report Number
    2520274-2013-02463
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DISTAL END OF THE WIRE WAS LEFT IN THE PATIENT IN THE TALUS BONE AND THE TOP PORTION OF THE WIRE WAS REMOVED WITH A WIRE DRIVER ON (B)(6) 2013. 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

    DURING AN OPEN REDUCTION INTERNAL FIXATION OF THE RIGHT ANKLE ON (B)(6) 2013, THE SURGEON INSERTED A 1.1MM THREADED GUIDE WIRE. THE SURGEON WAS UNHAPPY WITH THE TRAJECTORY ANGLE AND WHILE BACKING OUT THE GUIDE WIRE, THE GUIDE WIRE SHEARED OFF AT THE DISTAL END. THE DISTAL END OF THE WIRE WAS LEFT IN THE PATIENT IN THE TALUS BONE AND THE TOP PORTION OF THE WIRE WAS REMOVED WITH A WIRE DRIVER. IT WAS REPORTED THAT THE WIRE BROKE WHERE THE TREADS MEET THE SHAFT. THE SURGEON OBTAINED ANOTHER GUIDE WIRE AND CONTINUED REDUCING THE FRACTURE. NO ADDITIONAL TIME WAS ADDED TO THE SURGERY WAS REPORTED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203805 1.1MM THREADED GUIDE WIRE 150MM FZX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR