Product complaint # (b)(4).(b)(4).Investigation summary: examination of the returned instrument tray revealed the plastic coating on the brackets is delaminating.The investigation did not establish that a broader investigation or corrective action was necessary.Depuy-synthes 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.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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