Synthes is submitting this report as a result of remediation activities related to (b)(4) 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, investigation revealed the lack of service caused noise to occur and main body of device to turn.The device was repaired and returned to customer on 10/31/2012.The complaint is indeterminate.(b)(6).510k#: device is not distributed in the united states, but is similar to device marketed in the usa.Placeholder.
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