BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.1MM NON-THREADED GUIDE WIRE 150MM

    MDR report key: 3031524 · Received April 2, 2013

    Report

    Report Number
    3003506883-2013-10085
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    April 10, 2012
    Report Date
    April 10, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. NO IMPLANT DATE. NO EXPLANT DATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE K-WIRE BROKE WHEN DRILLING OVER THE K-WIRE. THE SURGEON HAD TO USE A NEW K-WIRE AND REMOVE THE BROKEN K-WIRE PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135258 1.1MM NON-THREADED GUIDE WIRE 150MM FZX SYNTHES ELMIRA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR