BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT-1.5/2 CRUCIF SELF-HOLD L9

    MDR report key: 3171650 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03196
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    February 17, 2012
    Report Date
    March 10, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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). THE MEASURABLE DIMENSIONS OF THE BROKEN TIP WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH TECHNICAL DRAWINGS AND AO ASIF SPECIFICATION. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATES 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 CROSS SECTION SURFACE SHOWS NO IRREGULARITIES WHICH INDICATE MATERIAL CONFORMITY AS WELL; THIS IS INDICATIVE OF EXCEEDING APPLIED MECHANICAL FORCE DURING REMOVAL SURGERY MAY HAVE CAUSED THE BREAKAGE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE TIP OF THE SCREWDRIVER SHAFT BROKE DURING THE REMOVAL OPERATION ON (B)(6) 2012. THE FRAGMENT WAS REMOVED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272475 SCRDRIVERSHAFT-1.5/2 CRUCIF SELF-HOLD L9 HXX SYNTHES GMBH 3483493

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR