Synthes is submitting this report as a result of remediation activities related to synthes (b)(4) 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 device failed the temperature and speed test.Functional testing was performed and revealed the control unit did not operate.This was attributed to normal wear.Device was repaired and returned to the customer on 2/4/2013.
|