Investigation: analysis and results: there is one previous complaint of this code-batch regarding the same issue.We manufactured and distributed in the market 2,844 units of this code-batch.There are no units in our stock.Four closed samples and two open samples with the thread broken were received.A knot pull tensile strength test was performed of the closed samples received and the results fulfil the requirements of the european pharmacopoeia (ep):1.29 kgf in average and 1.15 kgf in minimum (ep requirements: 0.51 kgf in average and 0.15 kgf in minimum).A review of the batch manufacturing record reveal this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Remarks: when working with optilene® 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: although the results of the samples received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.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.No corrective/preventive actions are needed.
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