Product complaint # = > (b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter address: (b)(6).Reporter is a (b)(6).(b)(4).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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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.H6: part 04.037.145s, lot 25p1417: manufacturing location: monument.Manufacturing date: november 14, 2019.Expiration date: november 01, 2029.This lot met all dimensional, visual, sterility, and packaging criteria at the time of release with no issues documented during the inspection or release that would contribute to this complaint condition.H6: a product investigation was completed: visual analysis of the returned sample revealed that the tfna femoral nail has broken in two (2) pieces, the broken fragments were returned.Also, the screws were returned, no defects were found in these devices.No other problem was reported.A dimensional inspection was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.The drawings reflecting the current and manufactured revisions were reviewed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.H11:.
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