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.Additional narrative: this report is for an unknown cage/spacer: t-pal/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a synthes employee.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 japan reports an event as follows: it was reported that the event occurred during an unknown surgery performed on (b)(6), 2023.After a cage was rotated, the surgeon tried to remove the cage from the shaft but couldn¿t.Therefore, the surgeon detached the shaft from a handle and then tried to remove the cage from the shaft.Since the attempt failed, the surgeon attached the shaft and the handle again.The tip of the shaft became bent because the surgeon forcibly attached the shaft and the handle.This event did not affect duration of surgery and the patient.The surgery was completed successfully with no surgical delay.No further information is available.This report is for an unk: cage/spacer: t-pal.This is report 2 of 3 for (b)(4).
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