B)(4).Investigation summary = > the complaint consisted of (1) the complaint consisted of (1) 254500131 attune tibial drill tower.(b)(4) attune ltl cem tibial drill were submitted as part of the reported event ¿play within the tower from use the returned attune tibial drill tower was functionally tested with each of the six returned attune ltl cem tibial drill.Each drill assembled/passed though the tower with no restrictions.The drill/tower interface was checked while the devices were assembled.There was no abnormal toggle/play identified that would create a non-conforming drilling procedure.Visual examination of the identified various areas of normal wear.The investigation did not find any evidence of product malfunction or product error and the need for corrective action is not indicated.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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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.Added: device identification (lot), device manufacture date, concomitant medical products.Corrected: device evaluated by mfr.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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