Samples received: there are no samples available for analysis.Analysis and results: the involved batch is not known.Without closed samples and/or defective samples a proper analysis cannot be performed.As no batch number is available, the batch manufacturing record cannot be reviewed.As stated in the instructions for use of the product, care should be taken to avoid damaging the needle when using the suture material.Always grasp the needle in a section 1/3 to 1/2 of the distance from the fiber attachment end to the needle point, never at the end where the fiber is attached or the needle point.Final conclusion: without samples we are not in position of studying if the affected product does not fulfil the specifications.In consequence, a proper analysis cannot be done and the case is not confirmed due to lack of evidence.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyze it.Please note that when no samples are received our analysis is very limited.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.
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