We are currently in the process of retrieving further information to perform investigation.We will provide a follow up report upon completion.This report is filed with the fda due to an event experienced with a device that is same/similar to those placed on the market in the usa, however, this event occurred outside of the usa.Please note: the submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
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No complaint devices were returned to optimized ortho by the customer.Thus, the device processing files were investigated which included reviewing ops processes, ops acetabular and femoral guides, and pre and post operative imaging of the patient.The design of patient specific guides has been determined to be unrelated to the failure mode of infection.The intended moist heat sterilisation method for sterilising the ops patient specific instruments has been validated to achieve sal 10-6 as per iso17665-1, as per opt-rsk-16 v111.Acetabular guide and femoral guide delivery products were designed within specification.There was no evidence to suggest that the ops technology provided to the primary surgery malfunctioned or was deficient.This failure mode is not associated with the use of ops technology in the primary surgery.There is no evidence to suggest that the use of ops technology in the primary surgery contributed to this revision event.Therefore, the case is now considered closed.This report is filed with the fda due to an event experienced with a device that is same/similar to those placed on the market in the usa, however, this event occurred outside of the usa.Please note: the submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
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