BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø3.5 L22 TI

    MDR report key: 2802510 · Received October 24, 2012

    Report

    Report Number
    8030965-2012-01111
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 15, 2012
    Report Date
    September 25, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. NOT PREVIOUSLY REPORTED. THE MEASURABLE DIMENSIONS OF THE RETURNED SCREW WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND (B)(4) 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. IT IS CLEARLY VISIBLE THAT THE HEXAGONAL PART IS BADLY DAMAGED. THIS LEAD US TO BELIEVE THAT FAR TOO MUCH MECHANICAL FORCE MIGHT HAVE BEEN APPLIED AND RESULTED IN THE BREAKAGE OF THE SCREW SHAFT. THE CROSS SECTION SURFACE SHOWS NO IRREGULARITIES. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A RIGHT DISTAL TIBIA FRACTURE WITH EXTENSION INTO THE DIAPHYSIS PROCEDURE, THE SCREW BROKE DURING INSERTION IN THE PLATE. THE BROKEN FRAGMENT REMAINS IN THE PATIENT. THE BROKEN SCREW HEAD WAS RETRIEVED AND RETURNED FOR EVALUATION. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTSCR Ø3.5 L22 TI CORTEX SCREW HWC SYNTHES GMBH 7859325

    Patients

    Seq Age Sex Outcome Treatment
    1 PLATE