It was reported that the expressew iii autocapture + suture passer device had an unspecified malfunction.During in-house engineering evaluation, the device was tested for its functionality where an eiii needle test was loaded into the device and was tested on a sample rubber strip.According to the investigation, when the trigger was actuated to deploy the needle, there was a slight resistance, and the deployment was rough causing stuck issue; and that to restore it to the original position, the needle trigger must be pushed back manually.There was no procedure nor patient involvement reported.No additional information was provided.
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Reporter is a j&j sales representative.The device manufacture date is currently unavailable.The product was returned to (b)(4) for evaluation.(b)(4) then conducted visual inspection and functional test of device received visual observations revealed signs of use but in expected condition.To test its functionality, an eiii needle test was loaded into the device and was tested on a sample rubber strip.When the trigger was actuated to deploy the needle, there was a slight resistance, and the deployment was rough causing stuck issue.To restore it to the original position, the needle trigger must be pushed back manually.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.The possible root cause for deployment issue can be attributed an improper maintenance would lead to bio-debris build up inside the expressew shaft causing wear of internal components leading to rough deployment issues.As per ifu, it is important to inspect the device prior to use to ensure proper mechanical function.Also, it is necessary to follow the instructions to cleaning and sterilization process and between uses, lubricate moving parts with the water-solubel lubricant in accordance with the manufacturer¿s instructions.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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