BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM

    MDR report key: 3183305 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03813
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 24, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDO
    PMA / PMN Number
    K953607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE MEASURABLE DIMENSIONS WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATES 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 ISO 5832-11 / ASTM F1295. NO PRODUCT FAULT COULD BE FOUND. OUR INVESTIGATIONS HAVE SHOWN THAT THE HEXAGON INSERT WAS DAMAGED AND WIDENED UP DUE TO INADEQUATE AND FORCIBLE HANDLING. THE OUTER DIAMETER OF THE SCREW GOT ENLARGED AND THEREFORE THE PLATE CANNOT PASS THE END OF THE SCREW. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. THE 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 CHINA AS FOLLOWS: TIP AND SHAFT OF SCREW BROKEN. IT WAS NOTED DURING SURGERY THAT THE TIP AND SHAFT OF THE SCREW WAS TOO LARGE AND COULD NOT BE INSERTED INTO THE PLATE. THE SURGEON USED ANOTHER SCREW TO COMPLETE THE SURGERY. THE PATIENT WAS NOT IMPACTED AND THE SURGERY WAS NOT BEEN DELAYED. THE EVENT DID NOT REQUIRE ADDITIONAL MEDICAL TREATMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282773 TI DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM APPLIANCE, FIXATION, DEVICE JDO SYNTHES GMBH 7941508

    Patients

    Seq Age Sex Outcome Treatment
    1