Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Device report from synthes (b)(6) reports an event as follows: it was reported that on an unknown date, after sterilization, the hex flexible screwdriver released a kind of oily water.There was no patient involvement.This report is for a hex flexible screwdriver.This is report 1 of 1 for (b)(4).
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