Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device registered within the u.S.(b)(4).Manufacturing site evaluation: samples received: 10 unopened pouches.Analysis and results: there are no previous complaints of this code batch, there are no units in stock.Tightness test to the sample received has been performed and the unit is tight.Tested the knot pull tensile strength of the sample received and the results fulfills the oem requirements.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfills the oem requirements.As instructed for use: "when working with monomax® suture material, great care should be taken to avoid any crushing or crimping damage of the monofilament by instruments such as forceps or needle holders".Final conclusion: complaint is not justified.Results of the samples received fulfills the oem requirements.Note is taken of this incidence in order to assess if new or additional actions are needed.Actions on product: based on the conclusion derived from investigation, it is not required to take an action on distributed product.A credit note for one box of product as a quality courtesy will be issued.Corrective/preventive actions: according to the internal procedures, there is no need to establish corrective or preventive actions.This complaint is recorded for trending analysis to assess if actions are needed in the future.
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