BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.1MM THREADED GUIDE WIRE 150MM

    MDR report key: 3030948 · Received April 2, 2013

    Report

    Report Number
    3003506883-2013-10075
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    August 30, 2011
    Report Date
    September 7, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE IS A VETERINARY PRODUCT. DEVICE IS SIMILAR TO A DEVICE MARKETED FOR HUMAN USE. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO PLACE A 1.1 THREADED GUIDE WIRE INTO A SUBCAPITAL PHYSEAL FRACTURE OF LABRADOR K-9 FOR REDUCTION AND THE TIP OF THE WIRE BROKE, LEAVING THE THREADED TIP IN THE DOG'S BONE. THIS HAPPENED THREE TIMES WITH THREE OF THE SAME SIZE GUIDE WIRE. THE SURGEON THEN PLACED A NON-THREADED K-WIRE OF THE SAME SIZE AND WAS SUCCESSFUL. THREE TIP FRAGMENTS REMAIN IN THE BONE. THIS IS REPORT 1 OF 3 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135255 1.1MM THREADED GUIDE WIRE 150MM FZX SYNTHES ELMIRA

    Patients

    Seq Age Sex Outcome Treatment
    1