BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER

    MDR report key: 3071187 · Received April 22, 2013

    Report

    Report Number
    1719045-2013-10761
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    July 9, 2012
    Report Date
    July 9, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    HEALTH 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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    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 DEVICE CODE: HWC. MANUFACTURING SITE ADDRESS IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TFN (TROCHANTERIC FIXATION NAIL) THE SURGEON WAS UNABLE TO INSERT HELICAL BLADE IF USING AIMING ARM AND INSERTION HANDLE. THE SURGEON ATTEMPTED IT TWICE BUT THE BLADE HIT THE NAIL BOTH TIMES. THE SURGEON DID REMOVE THE NAIL TO ENSURE IT WAS ASSEMBLED CORRECTLY, BUT THE BLADE HIT THE NAIL AGAIN AFTER THE NAIL WAS REIMPLANTED. THE SURGEON WAS ABLE TO INSERT THE BLADE WITH NO PROBLEM WITHOUT USING THE AIMING ARM AND INSERTION HANDLE. IT IS SUSPECTED THAT THE CAUSE IS OVERTIGHTENING OF THE INSERTION HANDLE CONNECTION SCREW. CONSULTANT REPORTS THAT THE MORE THE CONNECTION SCREW IS TIGHTENED, THE BLADE WOULD BIND UP IN THE NAIL. EVENT #1 OF 2 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172823 11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1