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.H10 additional narrative: d2b additional device product codes: hwc.D10 therapy date: (b)(6) 2023.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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Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent the surgery with the tna in question.The surgery was completed successfully without any surgical delay.After the surgery, the patient had infection.On (b)(6) 2023, the tna was removed to clean the infected area.The removal surgery was completed successfully without any surgical delay.This report involves one (1) tibial nail-advanced / 12mm 330mm / sterile.This is report 1 of 3 for (b)(4).
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