This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.This does not meet a complaint definition, the electronic complaint record will be voided.Product complaint #: (b)(4).Investigation summary: examination of the returned device has not identified product error regarding the reported event.There is no design or manufacturing requirement that the anti-rotational features of the device specifically line up to the screw holes.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.
|