BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE SHORT W/QUICK-COUPL

    MDR report key: 3193283 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-02351
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    May 16, 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. (B)(6). A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. ADDITIONAL EVALUATION, THE PERFORMED INVESTIGATION HAS SHOWN THAT THE RETAINING PIN FOR THE BAYONET COUPLING BROKE OFF. WE CAN UNFORTUNATELY NO LONGER ESTABLISH AFTER THE FACT THE PRECISE CAUSE OF THE DAMAGE. WE PRESUME THAT A TOO HIGH MECHANICAL LOAD CAUSED THIS DAMAGE. THE INVESTIGATION BASED ON THE MANUFACTURER AND MATERIAL DOCUMENTATION SHOWED THAT THE PRESENT ITEM FULLY CORRESPONDS TO THE SPECIFICATIONS. NO PRODUCT FAILURE COULD BE ASCERTAINED.

    Description of Event or Problem · 1

    RETAINING PIN BROKE OFF (SPRING AND SLEEVE STILL AT THE CLINIC). THIS IS 1 OF 1 REPORT FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294630 HANDLE SHORT W/QUICK-COUPL LXH SYNTHES GMBH 2629301

    Patients

    Seq Age Sex Outcome Treatment
    1