(b)(4).The dhr for the returned instrument was reviewed and found completely manufacturing facility as part of a 50 pc.Lot in july of 2021.It was found that this order was made from the correct materials and components and all approved processes were followed.It can then be stated that the alleged non-conformance inciting this complaint was not due to an error in the manufacturing process.Evaluation of the returned instrument as received shows that the distal handle is loose and separate from the instrument in the bag and the pivot screw that holds the distal handle into the handle assembly is missing.We are able to validate this complaint.Further evaluation shows that the back side of the proximal handle shows evidence of staking in 3 places around the threaded hole.Per ifu, which was included with this instrument at time of manufacture "as screws may become loose during normal operation of an instrument, inspect before and after use in order to ensure proper function." we are unable to determine what caused the screw to become loose and missing but mishandling and lack of proper maintenance 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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