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: device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter occupation: reporter is a j&j sales representative.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 synthes reports an event in canada as follows: it was reported that on (b)(6) 2023, during the surgery it was noted that the metal prongs at the tip had become deformed and could no longer properly retained the reamer heads that they were designed to retain.The item was deemed to be no longer functional, and was subsequently discarded.A replacement is required.It was identified by medical device reprocessing staff during routine inspection, the second complained item to be significantly discolored on the handle, and the thin metal shaft was bent at an incorrect angle.This item was deemed to be no longer functional and was discarded.A replacement is required.No patient consequences.This report is for one (1) 5.0mm flexible shaft.This is report 2 of 2 for complaint (b)(4).
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