On friday, (b)(6) , at (b)(6) hospital while implanting a attune size 3 fixed bearing tibial component in the right tibia of the patient, the attune tibial impactor split into two pieces.Surgeon, operating surgeon, removed the two pieces by hand.He then finished impacting the tibia into the cement mantle with the attune femoral impactor.Time delay was less than a minute.All pieces were retrieved.Surgeon did not mention whether he thought the instrument was deficient.
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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.Product complaint #: (b)(4).Investigation summary: the device associated with this report was not returned, however, photographs were provided for review confirming the reported breakage.Root cause and corrective action are documented in the capa system.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.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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