The device that was used in treatment was not returned for evaluation, with no additional information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause.Details surrounding the patient¿s resubmission to the hospital were not provided.Infections are potentially inherent to any surgical procedure.A review of the manufacturing records could not be performed because the lot number was not provided.However, at this time, we have no reason to suspect that the product did not meet specifications at the time of manufacture.A complaint history review found other related failures.Risk management files contain the reported failure mode.No update required.Instructions for use (ifu) contains recommendations and precautionary statements for proper use of product.A clinical/medical assessment was performed and determined no further actions are required.Smith and nephew will continue to monitor for any adverse trends relating to this product.No further investigation is required.
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