Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under care and handling of instruments, "surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling." under storage and shelf life, "instrument cases that have been processed and wrapped to maintain sterility should be stored in a manner to avoid extremes in temperature and moisture." (b)(4).Examination of returned device found no evidence of product non-conformance and confirmed reported condition.A conclusive root cause of the event could not be determined.This report is number 10 of 16 mdrs filed for the same event (reference 1825034-2016-02214 / 02229).
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