BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12MM/125 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER

    MDR report key: 3073627 · Received April 23, 2013

    Report

    Report Number
    1719045-2013-10816
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    June 3, 2012
    Report Date
    June 3, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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. ADDITIONAL COMMON DEVICE CODE HWC. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. PRODUCT DEVELOPMENT EVALUATION STATED THAT BASED ON EXAMINATION OF THE RETURNED DEVICE, THE LOCKING MECHANISM IN THE NAIL WAS IN THE LOCKED POSITION WHEN ATTEMPTING TO INSERT THE HELICAL BLADE AND THE LOCKING PRONG WAS GROSSLY DEFORMED AND CRACKED AS A RESULT. THIS ISSUE HAS BEEN NOTED ON SEVERAL PREVIOUS COMPLAINTS FOR TFN NAILS, THE INCORPORATION OF A REDESIGNED SHIPPING CAP HAS BEEN IMPLEMENTED TO ADDRESS THIS ISSUE. THE LOT NUMBER OF THE RETURNED NAIL INDICATES THAT IT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THE NEW SHIPPING CAP. ALSO, SINCE THE COMPLAINT WAS RECEIVED IN JUNE 2011, IT OCCURRED PRIOR TO THE 2012 TFN RECALL AND WOULD HAVE BEEN IN THE ORIGINAL PACKAGING AT THE TIME OF THE EVENT.

    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. ORIGINAL AWARENESS DATE IS (B)(6) 2012. ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2013.

    Description of Event or Problem · 1

    SALES CONSULTANT REPORTED THAT DURING A TFN, INSERTION OF THE HELICAL BLADE WAS NOT POSSIBLE BECAUSE THE LOCKING MECHANISM WAS ALREADY ENGAGED. AN ALTERNATE DEVICE WAS SELECTED TO COMPLETE THE PROCEDURE. THIS IS 1 OF 1 REPORT FOR EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173870 12MM/125 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER HSB SYNTHES MONUMENT 6780652

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR