Integra has completed their internal investigation on june 9, 2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: evaluation of returned device; one (1) used package of neurawrap nerve protector 3mm id x 2cm length corresponding to fg lot # 1135110 was reported as the complaint unit.Since the unit was used it was not returned for evaluation.Ten (10) retain sample units were visually inspected for product and packaging appearance.No anomalies were observed.All units met product and packaging specifications.Dhr review; no anomalies were reported during the packaging process of this lot that could be related to the reported condition.Neurawrap nerve protector 3mm id x 2cm length, fg lot # 1135110 was manufactured through the following processes: cutting, inspection, trays cleaning, tyvek lids stamping and inspection, packaging, packaging inspection, bulk boxing, bulk boxing inspection, sterilization, piggyback and outer box labels printing, labels inspection, labels application and boxing, final inspection, and product release processes.Complaints history; approximately (b)(4) units of neurawrap products have been shipped for sales purposes since 2013 until 02/10/16, resulting in a complaint occurrence rate of approximately (b)(4).This was determined by dividing the number of complaints in this category (1) by the number of units shipped for sales purposes of the neurawrap units.Conclusion: based on information provided on the complaint record and the failure analysis that was made taking into account the retain samples evaluation, the reported incident (use of expired product) could not be associated to the manufacturing / packaging process performed at integra.Complaint unit was labeled in an accurate manner and applicable procedures.However, during the investigation it was confirmed that as reported by the customer, the integra sales department was responsible for the inventory.Therefore, the reported condition is confirmed taking into account the information received by the integra¿s regional sales manager.
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