BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-03324

    MDR report key: 3171585 · Received June 15, 2013

    Report

    Report Number
    2520274-2013-03324
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    November 1, 2011
    Report Date
    November 1, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE MEASURABLE DIMENSIONS OF THE SCREWS COULD NOT BE CHECKED FOR ITS SPECIFICATION AS THERE WAS NEITHER ARTICLE NOR A LOT NUMBER PROVIDED. THE SAME APPLIES TO THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPER. THE CROSS SECTION SURFACE SHOWS NO IRREGULARITIES WHICH INDICATE MATERIAL CONFORMITY. AS NO FURTHER DETAILS WERE AVAILABLE, WE ARE NOT ABLE TO RELIABLY DETERMINE A CAUSE FOR THIS PROBLEM. THERE IS EVIDENCE THAT TOO HIGH OF A MECHANICAL FORCE INTO POSSIBLE CORTICAL BONE MAY HAVE CAUSED THESE BREAKAGES.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2011, TWO TITANIUM SELF TAPPING CORTEX SCREWS WERE INSERTED USING A MODULAR HAND SET. BOTH SCREW HEADS HAD SHORN OFF. REPORTEDLY, NOT A LOT OF FORCE WAS BEING APPLIED AND THE HEADS CAME OFF. THE BROKEN PARTS WERE RETRIEVED AND RETURNED. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272600 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1