BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA Ø10 SM 130° L200 SST

    MDR report key: 3192547 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04127
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 19, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. NO MANUFACTURING DEFICIENCIES WERE NOTED. BASED ON THE DHR REVIEW, THE EVALUATION, AND THE UNKNOWN CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NAIL CANNOT BE FIXED ACCORDINGLY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292254 PFNA Ø10 SM 130° L200 SST JDS SYNTHES GMBH 7866907

    Patients

    Seq Age Sex Outcome Treatment
    1