BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER

    MDR report key: 3032405 · Received April 3, 2013

    Report

    Report Number
    1719045-2013-10522
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    April 22, 2012
    Report Date
    April 22, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TFN PROCEDURE THE SURGEON HAD DIFFICULTY INSERTING THE HELICAL BLADE THROUGH THE NAIL, THE SURGEON MADE TWO ATTEMPTS AT INSERTING THE BLADE WITHOUT SUCCESS. WHEN HE REMOVED THE BLADE THE SECOND TIME, HE INSPECTED THE LOCKING MECHANISM IN THE NAIL, AND FOUND IT TO BE IN THE DOWN POSITION. HE ADJUSTED (BACKED OUT) THE SET SCREW SLIGHTLY, AND WAS THEN ABLE TO INSERT THE BLADE WITHOUT DIFFICULTY, AND COMPLETED THE PROCEDURE. NO PRODUCT TO RETURN. NAIL AND BLADE REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136711 12MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER HSB SYNTHES MONUMENT 6683660

    Patients

    Seq Age Sex Outcome Treatment
    1