Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 : a review of the device manufacturing records (dhr) was performed as part of this investigation.A manufacturing record evaluation was performed for the finished device 103544000, lot j95t02, and no non-conformances / manufacturing irregularities related to the malfunction were identified.Should further information come available that impacts the findings in this investigation it will be reopened.
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