Added: concomitant medical products.Corrected: device evaluated by mfr.Product complaint # (b)(4).Investigation summary: examination of the returned device confirms the complaint; the impactor has broken.Root cause attributed to product design 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, a follow-up medwatch will be filed as appropriate.
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