(b)(4).The device history review for the returned instrument was reviewed and found complete without any irregularities.This instrument was produced at the tecomet, inc.Kenosha, wi facility as part of a (b)(4)-pc lot in september of 2021.It was found that this order was made from the correct materials and components and all approved processes were followed.Evaluation of the returned instrument shows that the jaws are slightly loose, misaligned to each other, and the jaw pivot pin is slightly sticking out on one side of the outer tube assembly.We are able to validate this complaint.After the initial evaluation this instrument was dis-assembled to evaluate its internal components and it was found that the inner drive rod bosses are both damaged where they engage the jaws.We suspect that the damaged drive rod bosses caused the jaws to become slightly loose and misaligned in the closed position.We are unable to determine what caused the drive rod bosses to become damaged and for the jaw pivot pin to be slightly sticking out of the outer tube assembly but mishandling of this device at the end user's facility is suspected.All (b)(4) instruments from this lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for this product l ine.Due to these findings, no further actions will b taken in response to this complaint and this record will be deemed closed.
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