A sample was received to perform an investigation.A visual inspection of the device confirmed that the hinge was broken.In manufacturing, 100% inspection was performed on the appearance of the connectors before setting.Therefore, it seems that the hinge part cracked and damaged when using the epifuse connector.The cause and timing of occurrence were not identified.The root cause is likely due to the molding design of the product.A device history review (dhr) could not be performed as no lot number was available.Due to this information a supplier corrective action request (scar) was issued against supplier.Model#, catalog #, serial #, lot#, expiration date, other #, udi# , operator of device, mfr site and 510(k) are unknown.No product 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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