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.During pre-repair assessment performed by a technician, functional testing was performed and revealed the device overheated.An assignable root cause is undetermined.The customer replaced the device in lieu of repair.The device was returned to the customer unrepaired on (b)(4) 2012.
|