BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAD

    MDR report key: 4190333 · Received October 21, 2014

    Report

    Report Number
    8030965-2014-01499
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Report Date
    December 21, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, NOTED THAT THE FORWARD DIRECTION TRIGGER WAS BLOCKED. THE POOR PERFORMANCE WAS ATTRIBUTED TO NORMAL WEAR. IT WAS ALSO FOUND THAT THE DEVICE LACKED MAINTENANCE, AND/OR HAD NOT BEEN PROPERLY SERVICED. MAINTENANCE OF THE DEVICE WAS PERFORMED AND THE DEVICE WAS RETURNED TO THE CUSTOMER ON (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE IS A PARTIAL OBSTRUCTION NOT ALLOWING THE TRIGGER TO COMPLETELY RETURN DURING THE FORWARD STROKE. THIS IS REPORT 1 OF 1 FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667522 CAD HWE SYNTHES GMBH 3937

    Patients

    Seq Age Sex Outcome Treatment
    1