Product complaint # (b)(4).Investigation summary: examination of the returned device confirms the mount will not lock into place.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.The complaint sample consisted of (1) 250610110 attune rev tib cut blck mount, lot ab4206501.Examination of the returned device confirms the attune rev tib cut blck mount will not hold the attune revision tibial block r.The locking mechanism will not tighten onto the cutting block making it unable to hold the cutting block into place.A worldwide complaints database search was performed and found one other complaint ((b)(4)) where the attune rev tib cut blck mount would not hold the tibial cutting block.The root cause is determined to be undetermined.Due to the determination of the root cause no corrective action is being initiated but the complaints will be monitored through (b)(4).Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.(b)(4).
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