Product complaint (b)(4).Investigation summary: no device was received for examination.Therefore, the reported event could not be confirmed.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 investigation could not draw any conclusions about the current reported event without the device to examine.Based on the inability to determine a root cause.A need for corrective action is not indicated.Monitor complaints through sep-419.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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