Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j sales representative.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.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, depth gauges have become "sticky" and won't slide properly, making it difficult to get an accurate measurement.This report is for one (1) depth gauge for 2.0mm and 2.4mm screws.This is report 1 of 3 for complaint (b)(4).
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