Reporter: trudell is located in ontario, canada (previously reported as england) manufacturing site evaluation: change of the article from ff388r to ff438r.We received the pull-rod ff435202 for investigation decontaminated but no other component.Failure description - only the pull-rod ff435202 is available for investigation, but the jaw part ff435203 was not provided.Investigation - the analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.The breakage was most likely caused by an overload situation, e.G.Caused by due to a too high tractive force and/or torsion during handling.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 - the breakage was most likely caused by an overload situation, e.G.Caused by a too high tractive force and/or torsion during handling.Corrective action - according to sop sa-de13-m-4-2-04-000-0 (corrective action and preventive action), a capa is not necessary.
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