BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICAT OUT SHAFT

    MDR report key: 3130233 · Received May 24, 2013

    Report

    Report Number
    2520274-2013-02906
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    February 24, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE VISUAL EXAMINATION SHOWED THAT THE RUST CONTAINED REMAINS OF DETERGENT, WHICH IS A CAUSE OF RUSTING, REMAINS OF DETERGENTS LEADS TO CORROSION ON ORIGINALLY NON-RUSTING MATERIAL. THE INVESTIGATION DETERMINED THAT THE CLEANING, CLEANSING, OR DRYING OF PARTS DID NOT REMOVE ALL DETERGENTS, WHICH CAUSED THE CORROSION. INSTRUMENTS MUST BE CLEANSED EXTREMELY WELL AND DRIED ACCORDINGLY AND PROPERLY IN ORDER TO AVOID SUCH PROBLEMS. THIS COMPLAINT HAS BEEN DETERMINED TO BE INVALID. (B)(6). CORRECTION DEVICE AND EVALUATION WERE PART OF QUALITY RECORD AND AVAILABLE AT TIME OF INITIAL REPORT. PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATES A HOSPITAL IN (B)(6) REPORTED: THERE IS RUST ON THE SHAFT. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232599 APPLICAT OUT SHAFT LXH SYNTHES USA 3393607

    Patients

    Seq Age Sex Outcome Treatment
    1