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.Product complaint(b)(4).Investigation summary: examination of the returned device confirms the reported breakage.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint consisted of (1) 254500977 attune conv fb ps tb trl sz7, lot number bfa0p7w.Examination of the returned device confirms the reported event.The trial is fractured diagonally, posterior to the larger post.All pieces were returned for evaluation.A complaint database search on the provided product code family identified similar complaints.This type of damage to the balseals is consistent with using a device in a prying motion to disassemble the mating instruments after trialing.Hhe (health hazard evaluation) 103026031 was revisited in may of 2015 to evaluate balseal disassociation.Hhe/qrb (quality review board) 103045639 was held on june 1, 2015 and recommends a device correction.A device correction was initiated on june 12, 2015 with the following actions: closely follow ifu (0902-00-836) and inspect trials pre and post-operative for damage/breakage per surgical technique 0612-10-512 (page 51), check for balseal damage, if damage is observed, replace damaged component.Per surgical technique 0612-10-512 (page 53), emphasizing the correct use of the tibial trial extractor (product code 254500138) mandatory sales training by depuy sales consultants.(capa 4795).Capa-004795 determined the likely root cause to be related to misuse.Complaint trends will be monitored by post market surveillance through sep-419.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Examination of the returned device confirms the reported breakage.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Product complaint # = > (b)(4).Investigation summary = > examination of the returned device confirms the reported breakage.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot = > null.Device history batch = > null.Device history review = > null.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.H10 additional narrative: if information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .
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