BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT-HANDLE F/EXPERT TN+FN

    MDR report key: 3131889 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02238
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    January 13, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE MATERIAL WAS RECEIVED AND INVESTIGATED USING THE MANUFACTURING AND MATERIAL DOCUMENTATION, AND IT WAS REVEALED THAT ALL SPECIFICATIONS WERE MET AND CONFORMED TO. IN ADDITION, THE BREAK SURFACE CONVINCES A HOMOGENOUS STRUCTURE, WHICH INDICATES DEFECT-FREE MATERIAL QUALITY. THE PRESENT CASE PERTAINS TO AN ARTICLE FROM 2006. IT IS EVIDENT THAT THIS AIMING ARM HAS BEEN EXTENSIVELY USED, AND AS SUCH DISPLAYS THE ASSOCIATED DAMAGE. NO PRODUCT DEFECT COULD BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NOSE OF THE AIMING ARM BROKE OFF. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237249 INSERT-HANDLE F/EXPERT TN+FN LXH SYNTHES GMBH 1593326

    Patients

    Seq Age Sex Outcome Treatment
    1