Product complaint # (b)(4).Investigation summary: the device associated with this report was returned for analysis.Visual inspection of the returned sample revealed the device was broken and cracked, therefore the complaint condition can be confirmed.The broken fragment was not returned.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 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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