BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAD II

    MDR report key: 4102542 · Received September 19, 2014

    Report

    Report Number
    8030965-2014-01177
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    February 8, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES OUS 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. (B)(6). DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE MOTOR SEIZED AND JAMMED, THE UNIT IS DIRTY, THE GEAR IS WORN WHERE IT CONNECTS TO THE GEAR SYSTEM, CAUSING PLAY IN THE SWITCH. THIS WAS ATTRIBUTED TO FAULTY CARE AND MAINTENANCE. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRIGGER GOT STUCK AND DID NOT DETACH. ALSO, WHEN OPERATING, THE SAFETY NUT RETURNED AND CLOSED SO THAT THE DEVICE TURNED OFF. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581887 CAD II HWE SYNTHES GMBH 16905

    Patients

    Seq Age Sex Outcome Treatment
    1