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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 canada reports an event as follows: it was reported that on (b)(6) 2024, the tips of the depth gauges were found to be bent and/or broken at the shaft.The products were unable to give accurate length readings.The procedure was completed successfully with a surgical delay of 2 minutes by using replacement depth gauges.No fragments were generated, no additional medical intervention was required.There was no adverse patient impact.No further information is available.This report is for a depth gauge for 1.3mm and 1.5mm screws.This is report 2 of 3 for (b)(4).
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