Qn#(b)(4).The device history for the returned instrument was reviewed and found complete without any irregularities.The instrument was produced at the tecomet, inc.Kenosha, wi facility as part of a 50-pc lot in march of 2022.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 outer tube assembly is damaged, and the jaws are bent towards the left and the jaws are loose and misaligned, and the jaw rivet pin is pulled through one side of the damaged outer tube assembly.We are able to validate this complaint.After the initial evaluation this instrument was dis-assembled in order to evaluate its internal components and it was found that the inner drive rod is bent, and its bosses are both damaged where they engage the jaws.We suspect that the slightly damaged drive rod bosses caused the jaws to become loose and misaligned in the closed position.We are unable to determine what caused the drive rod to become bent and for it bosses to become damaged and for the jaw pivot pin to be pulled through one side of the damaged outer tube assembly but mishandling of this device at the end user's facility is suspected.All 50 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 line.Due to these findings, no further actions will be taken in response to this complaint and this record will be deemed closed.
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