BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    MDR report key: 3000697 · Received March 12, 2013

    Report

    Report Number
    1719045-2013-10324
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    November 21, 2011
    Report Date
    November 21, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. ORIGINAL AWARENESS DATE IS (B)(4) 2011. ADDITIONAL INFORMATION WAS RECEIVED (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    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 SAMPLE WAS NOT RECEIVED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THIS COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE.

    Description of Event or Problem · 1

    THIS REPORT IS FOR FILE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE, THE SURGEON INSERTED NAIL AND UPON INSERTING THE BLADE, BLADE WOULD NOT ADVANCE. X-RAYS WERE TAKEN TO REVEAL THAT THE LOCKING MECHANISM IN THE NAIL WAS ENGAGED. SURGEON REMOVED EVERYTHING AND ADJUSTED MECHANISM ON NAIL. SURGEON RE-INSERTED EVERYTHING AND COMPLETED THE PROCEDURE SUCCESSFULLY WITH NO HARM TO THE PATIENT. ALL HARDWARE IS CURRENTLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103652 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE HSB SYNTHES MONUMENT 6690202

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR