(b)(4).It is unknown if the device sample is available for evaluation.A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not received at our facility.A device history record review could not be conducted since the lot number was not provided.Regarding this issue a capa file (b)(4) was opened.According to the capa investigation so far the root cause for the issue was the positioning of the thread lead and the softness of the new resin used for the snap adaptor.Customer complaint cannot be confirmed, based only on the information provided, to perform a correct investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.If device sample becomes available at a later date this complaint will be re-opened.
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