BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE BLOCK FOR 2 COLUMN PLATE6 HOLE HEAD/RIGHT

    MDR report key: 3083452 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11145
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    July 13, 2012
    Report Date
    July 13, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PACKAGE WAS RECEIVED UNOPENED AND IN GOOD CONDITION WITH THE GUIDE BLOCK STILL PACKAGED IN THE BAG. THE SYNTHES USA LABEL, WHICH IS AFFIXED OVER THE EU LABEL. THEREFORE, BASED ON EXAMINATION OF THE RETURNED PACKAGE, THE ITEM WAS MISLABELED WHEN THE US LABEL WAS APPLIED AND THEREFORE THIS COMPLAINT IS VALID.

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (A/RE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOSPITAL ORDERED AND RECEIVED A DISTAL RADIAL SET. THE MATERIALS MANAGER AND THE SALES CONSULTANT DISCOVERED THAT THE PACKAGING FOR THE GUIDE BLOCK FOR 2 COLUMN PLATE WAS LABELED ON THE PACKAGE, HOWEVER THE PART INSIDE THE PACKAGE WAS DIFFERENT. PACKAGING IS FOR THE RIGHT GUIDE AND THE GUIDE INSIDE IS FOR A LEFT. THE PACKAGE IS STILL SEALED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184728 GUIDE BLOCK FOR 2 COLUMN PLATE6 HOLE HEAD/RIGHT FZX SYNTHES GMBH 10-5147

    Patients

    Seq Age Sex Outcome Treatment
    1