BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUN TIBIA Ø9 L345 SST

    MDR report key: 3182507 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03811
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 24, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO A DEVICE MARKETED IN THE UNITED STATES. DEVICE WAS RECEIVED FOR EVALUATION. THE MEASURABLE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. NO PRODUCT FAULT COULD BE DETECTED. IT IS CLEARLY VISIBLE THAT THE RETURNED NAIL IS PROXIMAL AS WELL AS DISTAL BENT. THE X-RAYS WERE COMPARED WITH THE RETURNED NAIL, AND IT WAS CONCLUDED THAT THEY ARE TWO DIFFERENT NAILS. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING THE SURGICAL PROCEDURE SURGEON REPORTED THAT NAIL BECAME BENT FROM THE 1/3 RD BEND OF THE NAIL. NAIL WAS EXPLANTED ON AN UNKNOWN DATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282378 SUN TIBIA Ø9 L345 SST NAIL, FIXATION, BONE JDS SYNTHES GMBH 2762760

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention