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.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.The initial reporter is a j&j employee.A review of the receiving inspection (ri) for 5.5 viper univ poly driver was conducted identifying that lot number gm4735202 was released in one batch.(b)(4).Supplier: depuy : (b)(4).As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Product was not returned.Based on the information available, it has been determined that no corrective and 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) 2022, the navigated expedium screw driver tip broke off while inserting a screw into the pedicle.The pedicle screw was inserted correctly, and the tip cold welded to the drive mechanism of the expedium screw, where the screwdriver tip meets the actual expedium screw.The tip could not be removed, and the rod and set screw were final tightened effectively.The procedure was completed successfully with no delay.This report involves one universal navigation expedium spine system quick connect poly driver 5.5.This is report 1 of 1 for (b)(4).
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