Device report from synthes reports an event in (b)(6) as follows: it was reported that (b)(6) 2022, the depth gauge f/scr ø4.5-6.5, 319.100 was bent and appears fragile.The surgeon not willing to use and risk breakage within patient.Procedure was completed successfully with five(5) minutes delay.No fragments generated.This report is for one (1) depth gauge f/scr ø4.5-6.5 meas-range up.This is report 1 of 1 for complaint (b)(4).
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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.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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