BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT-HANDLE F/PFN

    MDR report key: 3194930 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04091
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    April 5, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. (B)(6). A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE INVESTIGATION BY MEANS OF THE MANUFACTURING AND MATERIAL DATA HAS SHOWN THAT THE AVAILABLE INSTRUMENTS WERE MANUFACTURED ACCORDING TO THE SPECIFICATIONS (LOT 1291889 IN SEPTEMBER 2004, LOT 120127 IN NOVEMBER 2004). THESE AIMING ARMS ARE IN A DESOLATE CONDITION, IN PARTICULAR THE IMPACT PLATES AND AROUND THE SURFACES OF THE IMPACT PLATES. AS A RESULT OF NUMEROUS BLOWS FROM THE HAMMER, CHIPS OF CARBON ARE VISIBLE ON THE SIDES OF THE SURFACE AREAS OF THE IMPACT PLATES. THESE FINDINGS SHOW THAT THIS PROBLEM IS NOT A MANUFACTURING FAULT. A PRODUCTION FAULT COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 1

    THE CLINIC HAS FOUND SMALL PARTICLES ON THE AIMING ARMS AND NEEDS THE INFORMATION WHETHER THIS IS CARBON ABRASION OR CONTAMINATION FROM BLOOD, TISSUE ETC. THIS IS 2 OF 2 REPORTS FOR EVENT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292239 INSERT-HANDLE F/PFN FZX SYNTHES GMBH 1301279

    Patients

    Seq Age Sex Outcome Treatment
    1