BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS/DCS-SCR Ø12.5 L85 SST

    MDR report key: 3181268 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03746
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 23, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K791619
    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 FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATIONS. 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. NO PRODUCT FAULT WAS FOUND. THE INVESTIGATION HAS SHOWN THAT THE POSITIONING GROOVE OF THE SCREW HAS BEEN WIDENED UP DUE TO INADEQUATE HANDLING. THE GROOVE IS EXPANDED AND DAMAGED AND THEREFORE THE PLATE DOES NOT PASS THE SLOTTED END OF THE DHS-DCS SCREW. SUBJECT DEVICE WAS NOT IMPLANTED/EXPLANTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ANOMALIES WERE FOUND. PRODUCT DEVELOPMENT EVALUATION NOT YET COMPLETE. THIS DEVICE WAS USED FOR TREATMENT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING SURGERY ON AN UNKNOWN DATE, THE LAG SCREW WOULD NOT SLIDE OVER THE DHS PLATE. IT WAS NOTED THAT THE CONNECTION TABS ON THE END OF THE SCREW WERE SLIGHTLY DEFORMED. THE SURGEON USED A NEW LAG SCREW AND IT SLID OVER THE PLATE AS EXPECTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282885 DHS/DCS-SCR Ø12.5 L85 SST KTT SYNTHES GMBH 8301708

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR