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.H10 additional narrative: e3: reporter is a j&j sales representative.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 depuy synthes reports an event in canada as follows: it was reported that on march 27, 2023, during a routine medical device reprocessing the tip of the synream was identified damaged.Out of two of the metal prongs, one was bent at the tip incorrectly and on the other item, had become twisted slightly at the tip.Both items were deemed to be no longer functional, and were subsequently discarded, which requires replacements.No additional information is available.No patient consequences.This report is for one (1) 5.0mm flexible shaft.This is report 1 of 2 for complaint (b)(4).
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