BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.1MM THREADED GUIDE WIRE 150MM

    MDR report key: 3922836 · Received July 9, 2014

    Report

    Report Number
    2520274-2014-12455
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE SCOPE, OPEN REDUCTION INTERNAL FIXATION (ORIF) AND OSTEOCHONDRITIS TREATMENT THE TIP OF THE THREADED GUIDEWIRE BROKE OFF AFTER BEING DRILLED OVER WITH A 2.0MM CANNULATED DRILL BIT FOR A 2.4MM HEADLESS COMPRESSION SCREW. THE BROKEN SEGMENT WAS LEFT IN THE MEDICAL CONDYLAR OF THE PATIENT. THE BROKEN SECTION IS APPROXIMATELY 5MM-10MM IN LENGTH. NO PATIENT HARM WAS REPORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400610 1.1MM THREADED GUIDE WIRE 150MM GUIDE FZX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR