Product complaint # (b)(4).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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Product complaint # (b)(4).Investigation summary: could not lock the insert.During the surgery, it was found that the insert could not be locked.And it was easy to loosen and pull out.After replacing another insert with the same lot number.The loosening situation happened again.Please check the detail in the video which is in the attachment.The doctor decided to continue to complete the surgery, but it may cause potential patient risk.Replacing the insert caused that the procedure delayed by approximately 30 minutes.The patient is stable now.The product was not returned to depuy synthes, however a video was provided for review.See attachment "(b)(4)".The video investigation was able to confirm the loosening condition of the uni insert, however with the evidence provided nothing indicative of a device nonconformance was found for the sigma hp uni tib tray sz3 lmrl or if it contributed with the loosening condition.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was unconfirmed as the observed condition of the [sigma hp uni tib tray sz3 lmrl] would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device jg8000 lot number, and no nonconformances were identified.
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