Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Additional narrative: product complaint # (b)(4).Investigation summary: examination of the returned device did not find any evidence of product error.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: product code 110044610, lot number hj2044.Device history batch: null.Device history review: review of the device history records did not reveal any related manufacturing deviations or anomalies on the reported lot number (hj2044).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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