Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation, however, review of the provided photo confirmed the tip of the instrument was deformed.The investigation did not establish that a broader investigation or corrective action was necessary.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.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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.
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