BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR 02.7 L22 TI

    MDR report key: 2556666 · Received April 25, 2012

    Report

    Report Number
    8030965-2012-00155
    Event Type
    Malfunction
    Date Received
    April 25, 2012
    Date of Event
    March 17, 2012
    Report Date
    March 28, 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 RAW MATERIAL AND MANUFACTURING PAPERS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATION. THE MEASUREABLE DIMENSIONS OF THE SCREW FRAGMENT MET SPECIFICATIONS. THE HEXAGON RECESS OF THE SCREW HEAD IS STRONGLY DAMAGED. THIS IS A CLEAR INDICATION THAT VERY HIGH FORCES WERE APPLIED ONTO THE SCREW. THERE ARE STRESS MARKS AT THE SHAFT VISIBLE, WHICH INDICATED AN EXCESSIVE CONTACT WITH THE PLATE. BASED ON THESE FINDINGS IT IS POSSIBLE THAT A MECHANICAL OVERLOAD OCCURRED DURING USE CAUSED THIS BREAKAGE.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PROCEDURE, SURGEON INSERTED A CORTICAL SCREW AND HE DETERMINED IT WAS TOO LONG. SURGEON WAS BACKING OUT THE SCREW AND THE SCREW HEAD BROKE OFF. SURGEON WAS UNABLE TO RETRIEVE THE SHAFT OF THE SCREW AND IT REMAINS IN THE PT¿S BONE. THIS IS ONE OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTSCR 02.7 L22 TI CORTSCREW 02.7 L22 HWC SYNTHES GMBH 3775271

    Patients

    Seq Age Sex Outcome Treatment
    1 PLATE| SCREW