BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS

    MDR report key: 3000817 · Received March 12, 2013

    Report

    Report Number
    1719045-2013-10305
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    August 19, 2011
    Report Date
    August 19, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRODUCT INVESTIGATION VISUAL INSPECTION REVEALED THA THE PARTS WERE MANUFACTURED AND PROCESSED PER THE SPECIFICATION REQUIREMENTS. THE COMPLAINT CONDITION COULD NOT BE REPLICATED WITH THE RETURNED PARTS AND BASED ON THE AGE OF THE PARTS, THERE IS NO INDICATION OF ANY MANUFACTURING OR DESIGN RELATED ISSUES. THEREFORE, THIS COMPLAINT IS INVALID.

    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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TFN PROCEDURE, SURGEON COMPLAINED THAT THE TOLERANCES OF THE INSTRUMENTS WERE SLIGHTLY OFF, CAUSING MISALIGNMENT. THE HELICAL BLADE HIT THE NAIL AND THE SURGEON HAD TO JIGGLE THE HELICAL BLADE TO GET IT TO ALIGN WITH THE NAIL. THE SURGEON WAS ABLE TO PASS THE BLADE THROUGH THE NAIL TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103216 BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS FZX SYNTHES MONUMENT 5103087

    Patients

    Seq Age Sex Outcome Treatment
    1