A sample was received for investigation.A visual inspection confirmed that the hinge part of the connector was broken and split into two.During manufacturing process of the kit, the appearance of the connector is fully inspected for any deformation or damage before incorporating it into the kit.The following causes are possible, but the cause and timing of occurrence were not specified.The worker did not notice any damage during the inspection or hinges were cracked during transportation after shipping.A device history record (dhr) review found no discrepancies or anomalies relevant to the reported problem.A supplier corrective action request (scar) was issued to the supplier.No information has been provided to date) this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
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