Manufacturing device history record review was not performed because it is a supplier design issue.A product sample was received for evaluation.Visual testing was performed.Visual inspection found the connector has broken hinge.The root cause of the reported issue was found to be a design issue.An internal scar has been opened and the supplier recommended a redesign of the hinge area.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional corrective actions will be taken.Product information and mfr site are unknown.No information has been provided to date this remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
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