An investigation is currently underway.Upon completion, the results will be forwarded.Several attempts to gather information from the customer were made.To date, no response has been received.If additional pertinent information becomes available, the report will be updated.
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For additional information received from the customer regarding the product event.One sample was received and a visual inspection and functional test were performed and the reported issue was not confirmed.The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.This complaint will be considered as unconfirmed.A root cause could not be determined as it was unknown which adapter model was used during the procedure.For all lots produced, the supplier performs incoming inspection and verifies that the material meets retention and installation force acceptance criteria.As part of continuous improvement efforts and a corrective action, the supplier changed the inspection measurement technique from go / no go gauging to using a pulling / insert force test.Quality will continue to monitor this issue through incoming inspection and complaints.If additional information is received, the investigation will resume as needed.This complaint will be used for trending purposes.If information is provided in the future, a supplemental report will be issued.
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