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.Blank fields on this form indicate the information is unknown, unavailable or unchanged.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 technician, functional testing revealed the motor was rough running and seized due lack of maintenance of components.Customer was sent a replacement device on (b)(4) 2013.The 510k: device is not distributed in the united states, but is similar to device marketed in the usa.Placeholder.
|