BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATOR INNER SHAFT

    MDR report key: 3191442 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-02761
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    February 3, 2011
    Manufacturer
    SYNTHES GMBH
    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

    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 PART WAS RETURNED FOR EVALUATION. NO ERRORS WERE DETECTED DURING THE FUNCTION TEST. VISUAL INSPECTION SHOWED RESIDUES OF RUST ON INNER SOCKET AND OUTER SOCKET, INDICATING THAT THE DEVICE WAS LIKELY NOT DRIED CORRECTLY. A REVIEW OF THE MANUFACTURE AND MATERIAL DOCUMENTS SHOWED CONFORMITY WITH THE SPECIFICATIONS. NO PRODUCT DEFECTS WERE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE PART JAMMED AND WAS UNABLE TO FUNCTION. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291458 APPLICATOR INNER SHAFT LXH SYNTHES GMBH 3416683

    Patients

    Seq Age Sex Outcome Treatment
    1