Qn#: (b)(4).The customer did not return the sample; however one photo was provided of the defective sample.Visual inspection of the photo confirmed that the outer tray had cracked.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.The complaint of a cracked tray was confirmed by the photo the customer sent.A device history record review was performed and no relevant findings were identified.The probable cause of this defect is design related.A non-conformance has been created to further investigate this cracked tray, sterility issue.
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