BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAW BLAD 37/22*8*0.4/0.3

    MDR report key: 3171631 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02890
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    January 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    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. (B)(6). A REQUEST FOR THE DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN MADE. INVESTIGATION SHOWED THAT ARTICLE 519.520/LOT 7686668 IS IN THE PACKAGE INSTEAD OF 532.045/LOT 7686650 AS SHOWN ON LABEL. THIS IS DEFINITELY A PACKAGING FAULT WHICH WAS UNFORTUNATELY NOT DETECTED DURING THE CONTROL PROCEDURE. SYNTHES IS NOT AWARE OF ANY OTHER COMPLAINTS REGARDING TO THIS ARTICLE. REFERRING TO OUR RISK ANALYSIS WE DECIDED NOT TO INTRODUCE FURTHER ACTIONS AND HANDLE THIS AS AN ISOLATED CASE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS DISCOVERED ON AN UNKNOWN DATE THAT THERE WAS THE WRONG ITEM IN PACKAGE. THE 14MM WIDTH SAW BLADE WAS RECEIVED INSTEAD OF THE DESIRED 8MM WIDTH SAW BLADE. IT IS UNKNOWN WHERE THIS WAS FOUND. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272511 SAW BLAD 37/22*8*0.4/0.3 GFA SYNTHES GMBH 7686650

    Patients

    Seq Age Sex Outcome Treatment
    1