Device report from canada reports an event as follows: it was reported that on (b)(6), 2021, the depth gauge was severely bent and no longer usable.Item has been discarded and no lot number is available.No further information is available.This report is for a depth gauge for 2.0mm and 2.4mm screws.This is report 1 of 1 for pc-(b)(4).
|
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.
|