No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.As a result of observing the connector, it was confirmed that the hinge was broken.Therefore, it seems that the hinge part cracked and damaged when using the connector.However, the cause and timing of occurrence were not identified.The reported event was confirmed.The root cause was not identified.Udi # is unknown.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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