Device report from synthes reports an event in canada as follows: it was reported that on an unknown date, the brown composite handles of the small hex screwdrivers are degrading, leaving brown stains and marks on sterilization containers and some have even begun to chip.Hooks on depth gauges seem worn causing difficulty measuring screw lengths.There was no patient consequence.This report involves one (1) depth gauge for 2.7mm & small screws.This is report 7 of 7 for (b)(4).
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Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.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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