BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø3.5 L30 TI

    MDR report key: 3030603 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-01310
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 5, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    PMA / PMN Number
    K031276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT WAS RETURNED AND THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MEASURABLE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE 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 SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. THE CROSS SECTION SURFACE SHOWS NO IRREGULARITIES WHICH INDICATE MATERIAL CONFORMITY AS WELL. WE HAVE TO ASSUME THAT TOO HIGH APPLIED MECHANICAL FORCE MAY HAVE CAUSED THE BREAKAGE.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: THE PATIENT HAD A TIBIAL DIAPHYSIS FRACTURE. SURGEON WAS USING PLATES AND SCREWS: DURING INSERTION OF A CORTICAL SCREW FOR FIXATION OF THE 3RD BONE PARTICLE THE SCREW BROKE. SURGEON ASSUMED WAS THAT A TAP LIMIT WAS INSUFFICIENT HE ALSO NOTED THE PATIENT WAS YOUNG MALE AND HIS BONE QUALITY WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134569 CORTSCR Ø3.5 L30 TI KWQ SYNTHES GMBH 7980808

    Patients

    Seq Age Sex Outcome Treatment
    1