BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA BLADE L90 TAN

    MDR report key: 3171646 · Received June 15, 2013

    Report

    Report Number
    2520274-2013-03391
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    March 12, 2012
    Report Date
    March 14, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. 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)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE BLADE WAS FUNCTIONALLY TESTED, NO PROBLEMS WERE FOUND. THE BLADE IS FULLY FUNCTIONAL WITH ONLY A FEW SCRATCHES ON THE SIDE VISIBLE. THE MALFUNCTION WAS NOT ABLE TO BE REPRODUCED. FURTHER INVESTIGATION SHOWED CONFORMITY OF THE ARTICLE IN QUESTION TO THE COMPANY SPECIFICATION AND NO APPARENT FAULT OF MATERIAL OR MANUFACTURING WAS DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2012, THE PROXIMAL FEMORAL NAIL A (PFNA) BLADE WAS UNABLE TO BE UNLOCKED AFTER ATTACHMENT TO THE IMPACTOR INSTRUMENT. THE TIP OF THE BLADE WAS REPORTED AS NOT FREELY SPINNING SO THE BLADE WAS NOT IMPLANTED. A DIFFERENT BLADE WAS OPENED AND IMPLANTED USING THE SAME IMPACTOR INSTRUMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272522 PFNA BLADE L90 TAN HSB SYNTHES USA 2722858

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR