Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: e3: reporter is a j&j employee.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h4, h6: 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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It was reported that on an unknown date during a multiloc procedures, the drill bit hit the nail for the posterior, anterior and direct anterior screw.The sleeves were tested before and unsure what happened.Perfect circle procedure was performed proximally.There was a patient delay.It was unsure that the jig was bent or not due to rotating jig intraop, but surgeon wants everything replaced.There was a surgical delay of 5 minutes.There was no patient consequences.This report is for one (1) aim arm/lat/f/multiloc proximal hum nl this is report 2 of 9 for complaint (b)(4).
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