Manufacturing site evaluation: product not available for investigation.Investigation: no product at hand.Batch history review: the traceability of articles without batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer (backtrack).In addition, the raw materials, semi-finished parts, etc.Used for the order are documented in the manufacturing history records (dhr - device history records).This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.Rationale: as the product is not available for investigation an exact cause cannot be determined at this moment.Based on the information from customer and the knowledge of the product, the root cause of the error is most probably usage related.The failure is described in the relevant risk analysis and in the corresponding ifu.Such breakages are caused by overloading of the mouth part, e.G.By grasping too hard tissue or bones, by using a blunt instrument which causes the need of higher forces and finally results in overloading.Corrective action: according to sop (b)(4) (corrective action & preventive action) a capa is not necessary.
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