BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø3.5 L36 TI

    MDR report key: 2964262 · Received February 15, 2013

    Report

    Report Number
    8030965-2013-00484
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 18, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MEASURABLE DIMENSIONS OF THE RETURNED SCREW WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO ASIF SPECIFICATION. ALSO 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. UNFORTUNATELY NO FURTHER DETAILED INFORMATION HAS BEEN GIVEN. THIS LEAD US ASSUME THAT TOO MUCH APPLIED MECHANICAL FORCE, SLANTING DIRECTION, DURING THE SCREW PLACEMENT HAS LEAD TO THE BREAKAGE OF THE SCREW SHAFT. THE CROSS SECTION SURFACE SHOWS NO IRREGULARITIES WHICH INDICATE MATERIAL CONFORMITY AS WELL. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    .A DEVICE REPORT FROM (B)(4) INDICATES A HOSPITAL IN (B)(6) REPORTED: PROCEDURE STARTED WITH THE FIXATION OF THE FIBULA, THEN DUE TO LACERATIONS ON THE MEDICAL FACE OF THE TIBIA, THE SPECIALIST USES A LCP 3.5 WARM PLATE AND CORTICAL SCREW, DURING THIS INSERTION A CORTICAL SCREW HEAD BROKE OFF AND THE SHAFT REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69190 CORTSCR Ø3.5 L36 TI CORTSCREW HWC SYNTHES GMBH 8067040

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR