DEVICE EVALUATION: DISTRIBUTOR RETURNED DEVICES FOR EXCHANGE ON 12-OCT-2017; THE REPORTED NON-CONFORMITY WAS CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. A REVIEW OF PREVIOUS COMPLAINT HISTORY SHOWS THAT NO SIMILAR COMPLAINTS HAVE BEEN REPORTED. ALL AVAILABLE DEVICES IN INVENTORY MANUFACTURED DURING THE SAME TIMEFRAME WERE VISUALLY INSPECTED FOR UNSEALED POUCHES. NO ADDITIONAL IMPACTED DEVICES WERE IDENTIFIED. POTENTIAL CONTRIBUTING MANUFACTURING FACTORS HAVE BEEN CONSIDERED AND CORRECTIVE ACTIONS HAVE BEEN INITIATED. A GOOD FAITH EFFORT WILL BE MADE TO INSPECT ALL REMAINING INVENTORY FOR THIS ISSUE PRIOR TO SHIPMENT. (B)(4).
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Patient 1
ON SEPTEMBER 27, 2017, IT WAS REPORTED BY OUR CONTRACT DISTRIBUTOR (B)(4) IN (B)(4) THAT THE OUTER POUCH FOR PART CRANIOTOMY GAP WEDGES (OP82011); LOT 00855421005727 018141116 WAS NOT SEALED. NO PATIENT OR END USER INVOLVEMENT.