A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.The suspect device was returned for investigation and visual and functional testing was performed.As a result of observing the sample, it was confirmed that the hinge part of the suspect device connectors was broken and split in two parts.At the manufacturing process of the kit, the suspect device was thoroughly inspected and the appearance of the suspect device connector for any deformation or damage before incorporating it into the kit.Therefore, the following possibilities are confirmed, but the cause and timing of occurrence were not specified.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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