Conclusion and justification status for mdr: the products associated with this reported event were not returned for examination.A complaint database search has identified a trend for this failure within the 2274 quickset drill family.Previous investigations have determined that user error is the likely root cause.As a result of trending health hazard evaluation, (b)(4) was conducted.The investigation did not establish the need for corrective action.No evidence was found of product or design error as a contributing factor.Subsequent complaints will be monitored under sep 419 post market surveillance.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
|