BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP DHS-PLATE 135° 4HO L38/92 SST

    MDR report key: 3200010 · Received July 1, 2013

    Report

    Report Number
    8030965-2013-04217
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 5, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED AND EVALUATED. THE RELEVANT DIMENSIONS OF THE SCREW AND THE PLATE 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, MANUFACTURING PROCESS, MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD ISO 5832-1 (1.4441). NO PRODUCT FAULT COULD BE DETECTED. 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. THE PLATE ITSELF WAS TESTED WITH OTHER SCREWS AND IS STILL FULLY FUNCTIONAL. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO A DEVICE MARKETED IN THE UNITED STATES. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE DHS LAG SCREW WOULD NOT FIT THROUGH THE DESIGNATED HOLE IN THE DHS PLATE. ANOTHER PLATE AND SCREW WERE USED. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299910 LCP DHS-PLATE 135° 4HO L38/92 SST HRS SYNTHES GMBH 8267430

    Patients

    Seq Age Sex Outcome Treatment
    1