Product complaint # (b)(4).Investigation summary: the device associated with this report was returned for analysis.After physical review, it was identified the device has cracked, therefore the allegation can be confirmed.Additionally, the device was found to be broken from a small section of the surface.The broken fragment was not returned for examination.Depuy considers the investigation closed.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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