BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER DRIVE

    MDR report key: 4090518 · Received September 15, 2014

    Report

    Report Number
    8030965-2014-01352
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    November 21, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE LOWER TRIGGER GOT STUCK. THIS WAS ATTRIBUTED TO NORMAL WEAR. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2012. PLACEHOLDER

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DEVICE KEPT RUNNING. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569638 POWER DRIVE GEY SYNTHES GMBH 35981

    Patients

    Seq Age Sex Outcome Treatment
    1