Additional device product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.(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 on (b)(6) 2020, the patient underwent removal of retrograde/antegrade femoral nail due to femoral nonunion.Insertion of a new retrograde/antegrade femoral nail (rafn), osteotomy, and insertion of angled blade plate were done.The revision procedure was successfully completed.The patient outcome is unknown.This report is for one (1) 13mm ti cann retro/antegrade femoral nail-ex/360mm-sterile.This is report 1 of 7 for (b)(4).
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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.H3, h4, h6: part 04.013.752s, lot 36p6167: manufacturing location: monument.Manufacturing date: january 22, 2020.Expiration date: december 31, 2028.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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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