Examination of the returned device confirms the reported event of a missing balseal.(b)(4) recommended a device correction which was initiated on june 12, 2015.Capa-(b)(4) determined the likely root cause to be related to misuse, and requires mandatory sales training on proper use and application of the device by depuy sales consultants.Capa-(b)(4) will also monitor the mandatory field training.The need for further corrective action was not indicated.Continue to monitor disassociation events per post market surveillance sep-(b)(4).Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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