A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned to manufacturer for evaluation, and a thorough investigation could not be completed as no lot number has been identified/confirmed in this case.Since the screw remains in the patient, no physical, material, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained.A general review of the manufacturing and inspection records did not reveal any contributing information/trends.
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