Integra completed its internal investigation (b)(6) 2015.The investigation included: method: review of device history records.Review of complaint management database for similar complaints.Results: there were no material non-conformances or variances associated with this lot of implants.A query in the complaint database did not identify other customer complaints associated with a reported distribution of expired universal2 total wrist implants.The query was limited to the time frame of 2012 to 2015 year to date.The five complaints associated with the distribution of expired implants are the only ones associated with the universal2 total wrist system.A review of sales figures determined that 5,070 individual universal2 implants were sold worldwide from (b)(6) 2015.The shipment of five expired implants results in a failure rate of 0.0986%.Conclusion: based on the information that was provided from the complainant, integra was able to confirm that expired product was shipped from integra (b)(4) to a hospital.An investigation conducted by integra (b)(4) quality assurance and regulatory affairs identified the root cause as a breakdown in the inspection process for the release of product to the field.Integra (b)(4) initiated a capa to address this issue.
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