Product complaint # (b)(4).Investigation summary: no information received with this individual complaint indicated that a broader investigation or corrective action was necessary the number of complaints received for this failure mode will continue to be monitored and product updates/ recommendations will be implemented at the post market surveillance review dependent upon occurrence ratings.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 required.Device history lot: device history reviewed 05 dec 18.2 unrelated non-conformance's on this lot number.Final micro and sterility tests passed.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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