This complaint is justified.The complaint reason is a human error during the production process.Our complete stock of spii rasps was checked and no further missing welding seams have been discovered.We assess this case as a single incident.As a preventative action all concerned departments have been informed.The affected employees were trained on this complaint.We will keep the market monitored.This event occured outside of the us and involves a product that was manufactured outside of the us.However, because the affected product is also marketed in the us, (b)(4) is submitting this mdr to ensure full compliance with 21 cfr part 803.Complaint no: (b)(4).
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