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.Complainant part is not expected to be returned for manufacturer review/investigation.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, a follow-up will be filed as appropriate.
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Device report from canada reports an event as follows: it was reported that on (b)(6) 2022, the ¿teeth¿ on one end of the 2.4/1.8mm double drill sleeve are chipped, and the mini quick coupling handle no longer accepts a quick coupling attachment.Neither are in working condition.This event did not occur intra op, there are no reported patient consequences or surgical delays.No further information is available.This report is for a handle with mini quick coupling.This is report 2 of 2 for (b)(4).
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