BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR 4.5 L34 SST

    MDR report key: 2841401 · Received October 23, 2012

    Report

    Report Number
    8030965-2012-01108
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 24, 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

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

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. INVESTIGATION COORDINATED BY SYNTHES (B)(4) . REPORT RECEIVED INDICATES THE MEASURABLE DIMENSIONS OF THE BROKEN CORTEX SCREW WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF 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. THE EXACT CAUSE WHICH LED TO THE BREAKAGE CANNOT BE DETERMINED AS NO FURTHER DETAILED INFORMATION HAS BEEN AVAILABLE. VISUAL INSPECTIONS NOTED THAT THE HEXAGONAL PART (UPPER PART) IS DAMAGED/DEFORMED. IT IS POSSIBLE THAT 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.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED. PT FELL FROM HIS OWN HEIGHT IN RIGHT HIP REGION. DURING THE PROCEDURE, THE SURGEON WAS RE-TIGHTENING A SCREW AND THE SCREW HEAD BROKE OFF. THE SHAFT OF THE SCREW REMAINS IN THE PT. IT WAS NOTED SURGEON DID NOT RETRIEVE THE SCREW SHAFT DUE TO PT'S BAD HEALTH CONDITION. THIS IS 1 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTSCR 4.5 L34 SST CORTSCREW HWC SYNTHES GMBH 7996593

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW| PLATE