BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER

    MDR report key: 3051866 · Received April 10, 2013

    Report

    Report Number
    1719045-2013-10637
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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. 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)

    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. THE MANUFACTURING EVALUATION SHOWED THAT THE PRODUCT WAS RECEIVED WITH THE LOCKING PRONG BROKEN. IT APPEARS THAT THE LOCKING MECHANISM WAS ENGAGED AT THE TIME OF IMPLANTATION. A DETERMINATION AS TO WHEN THE ASSEMBLY WAS MOVED FROM THE SET POSITION CANNOT BE MADE. IT IS CONCLUDED THAT THIS COMPLAINT IS INDETERMINATE. (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR THIS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TFN PROCEDURE THE SURGEON INSERTED THE NAIL AND WAS DRILLING TO INSERT THE SCREW, WHEN THE DRILL HIT THE NAIL AND CAUSED A FEW METAL SHAVINGS TO COME OFF THE NAIL. SURGEON REMOVED THE NAIL AND ALL THE SHAVINGS. SURGEON SELECTED ANOTHER NAIL AND COMPLETED THE PROCEDURE. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148327 11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER HSB SYNTHES MONUMENT 6666780

    Patients

    Seq Age Sex Outcome Treatment
    1