A device history record review was performed and indicated a design issue was identified.A product sample was received for evaluation.The reported connector was not present.A photo provided with the complaint was inspected and shows a broken hinge.Unable to determine the root cause of the reported issue.This issue is monitored by pattern trend analysis and corrective actions (if any) will be implemented.Based on 200,000 uses per year it will take 20 complaints to increase the risk level to moderate.The proposed threshold will allow for review before the risk level increases.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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