Examination of the submitted device confirmed the brackets are delaminating.The instrument cases lot codes indicate manufactured dates of 2008 through 2010.A search of the complaint database found additional reports of bracket delamination for sigma hp instrument cases.Previous investigation did not conclusively determine the root cause, although it is the supplier manufacturing process related.Details of this issue have been documented through (b)(4).Monitor through trend analysis via (b)(4).Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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