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.Device is not distributed in the united states, but is similar to device marketed in the usa.During pre-repair assessment performed by a technician, functional testing was performed and revealed the device ran hot and rough.This was attributed to normal wear.Inspection and maintenance were performed and the device was repaired and returned to the customer on (b)(4) 2012.Placeholder.
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