BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR PLUSDRIVE Ø1.3 SELF-TAP L8 TAN

    MDR report key: 3161349 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-03027
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    June 18, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    PMA / PMN Number
    K102656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). AN ADDITIONAL EVALUATION WAS PERFORMED AND THE REPORT STATES THE FOLLOWING: THE VERIFICATION OF THE RAW MATERIAL TEST CERTIFICATE AND THE PRODUCTION DOCUMENTATION OF ITEM (B)(4) SHOWED THAT THERE ARE NO DEVIATIONS WITH REGARD TO MATERIAL ANALYSIS, TENSILE STRENGTH, STRUCTURAL STABILITY AS WELL AS PRODUCTION. THE VALUES CORRESPOND TO THE (B)(4) SPECIFICATIONS AND (B)(4). FURTHER, THE BROKEN SURFACE OF THE CORTICAL SCREW IS HOMOGENOUS AND DOES NOT SHOW SIGNS OF ANYTHING OUT OF THE ORDINARY, WHICH INDICATES GOOD MATERIAL QUALITY. DUE TO THESE FINDINGS AND DESCRIPTION OF THE METAL REMOVAL, WE CAN ASSUME THAT A BRIEF MECHANICAL OVER-EXERTION WHEN REMOVING THE SCREW CAUSED THE SCREW HEAD TO BREAK OFF. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING A PROCEDURE THE SCREW HEAD BECAME DEFORMED WHEN THE METAL WAS BEING REMOVED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263131 CORTSCR PLUSDRIVE Ø1.3 SELF-TAP L8 TAN JEY SYNTHES GMBH 2264928

    Patients

    Seq Age Sex Outcome Treatment
    1