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.E3: reporter is a j&j employee.D9: complainant part is not expected to be returned for manufacturer review/investigation.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 (b)(6) 2023, during an orthopedic surgery tibial plateau open reduction internal fixation with ordinary use, a 2.5 mm hexagonal driver 314.550 became sheared off at the tip.The tip could fused to the head of the screw.Tip was unable to be retrieved.Attempting to remove would cause more harm so intentionally retained.This report is for one (1) 2.5 hex screwdriver shaft small/qc/165 this is report 1 of 1 for complaint (b)(4).
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