Sunmed investigated the affected device and was unable to replicate the fracture characteristics of the stem failure mode.Dimensional and visual inspection of the components and tools did not indicate an damage or excessive wear.During the investigation diaphragms were intentionally damaged, but the product still performed as intended.Additionally, we performed a historical customer complaint review (external data) and a nonconforming product review (internal data) and found no occurrences of this failure mode.We have not been able to determine the root cause and consider this to be an isolated incident.
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