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 product codes: ktt, hwc.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: reporter is a j&j employee.(b)(4).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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It was reported that the patient originally had surgery to implant a 17-hole plate on (b)(6) 2022.Then, it was reported that on (b)(6) 2022, the plate was broken.A revision surgery was performed on (b)(6) 2022 using a straight broad plate to replace the curved broad plate that was broken.This report involves one 4.5mm broad lcp® plate 16 holes/296mm.This is report 1 of 1 for (b)(4).
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