BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPERT TN Ø8 SOLID L285 TAN DBLUE

    MDR report key: 3133002 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02406
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. THE COMPLAINED ARTICLE WAS SEND TO OUR PRODUCTION PLANT FOR EXTENSIVE INSPECTION. ACCORDING TO THE STATEMENT THEY FOUND REMAINING DIRT OVER THE WHOLE SURFACE AREA. THE MARKING WAS DIFFICULT TO READ. AFTER THE INSPECTION THE ARTICLE WAS CLEANED THOROUGHLY WITH ALCOHOL AND THE MARKING WAS READABLE WITHOUT FURTHER ADO IN HARMONY WITH OUR SPECIFICATIONS. THE COMPLAINT CONDITION IS LIKELY THE RESULT OF A CONTAMINATED SURFACE DUE TO THE FACT THAT THE MARKING WAS READABLE COMPLETELY AFTER CLEANING. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE, IT WAS NOTED THAT INFORMATION SUCH AS LENGTH, DIAMETER, PRODUCT NUMBER, AND LOT NUMBER ARE NO LONGER VISIBLE ON THE IMPLANT. THERE ARE ABOUT 18-20 NAILS IN THE SET THAT ARE AFFECTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235108 EXPERT TN Ø8 SOLID L285 TAN DBLUE JDS SYNTHES GMBH 7682243

    Patients

    Seq Age Sex Outcome Treatment
    1