It was reported that on (b)(6) 2023, the surgeon did a case with the tfna standard set.When the surgery was finished, the tfna buttress compression nut could not be taken off the large trocar.It seemed like the threads on the trocar were cross-threaded, and the two pieces couldn¿t be separated.There was a delay of 5-10 minutes due to the event, and the surgery was completed successfully.No other medical intervention was required.There were no patient consequences.This report involves one blade/screw guide sleeve.This is report 2 of 2 for (b)(4).
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Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.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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