BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA-II BLADE L100 TAN

    MDR report key: 3171607 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02937
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    June 29, 2011
    Report Date
    July 8, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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. CONTACT OFFICE: FIRST AND LAST NAME WAS CORRECTED TO (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. 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. THE INVESTIGATION OF THE COMPLAINED DEVICE BY OUR PRODUCT DEVELOPMENT ENGINEER SHOWED THAT THE END CAP IS TWISTED AND THEREFORE JAMMED INTO THE SLEEVE. THERE IS EVIDENCE THAT THE USER TURNED IN WRONG DIRECTION DURING REMOVAL PROCEDURE. IT IS IMPORTANT TO KNOW THAT THE BLADE HAS A LEFT TURNED THREAD. BECAUSE OF THAT THE SYSTEM IS JAMMED. REVIEWING MANUFACTURING AND MATERIAL DOCUMENT SHOWS NO DEVIATION TO THE SPECIFICATION.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A SURGERY ON (B)(6) 2011, THE SURGEON WAS UNHAPPY WITH THE DIRECTION OF INSERTION OF THE PROXIMAL FEMORAL NAIL A (PFNA) BLADE. THE SURGEON REMOVED IT FROM THE PATIENTS FEMORAL HEAD USING THE REMOVAL DRIVER. HE THEN ATTEMPTED TO REMOVE IT FROM THE REMOVAL DRIVER TO REINSERT THE BLADE, BUT HE COULD NOT TAKE THE BLADE OUT FROM THE REMOVAL DRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272455 PFNA-II BLADE L100 TAN HSB SYNTHES GMBH 2576512

    Patients

    Seq Age Sex Outcome Treatment
    1