Upon routine inspection in spd, it was noted that two attune items have been broken in prior surgeries.These events were not reported during surgery, so no adverse effects were reported.The attune articulating shim has cracks on both sides, the ballseals are still in tact.As for the attune tibial handle, the red spring loaded button has broken off and can no longer be used.
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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 investigation identified the device was crack.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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