It was reported by the sales rep that during an unknown procedure on (b)(6) 2022, it was observed that the expressew ii flexible suture passer -ns was unable to fully load the needle.According to the report, the device got jammed about halfway through the shaft and won¿t advance any further.During in-house engineering evaluation, it was determined that the upper jaw was slightly loose; and the jaws did not fully close at once.Another like device was used to complete the procedure.No patient consequences or surgical delay reported.No additional information was provided.
|
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.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Visual observations revealed marks of wear in the entire device.The upper jaw was slightly loose.The jaws do not fully close at once.At the time to perform the functional test, when trying to upload a needle it was noticed that a needle was already stuck in the shaft.It cannot be removed since the white flag was missing.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.Lot number on the device indicates this device is 12 years old.This failure can be attributed to fair wear and tear of the device due to repeated use and sterilization cycles; an improper maintenance causing wear of internal components.Also, for the needle stuck can be attributed to repeatedly passing the needle through excess tissue causes the needle to fatigue and breake.Also, an improper maintenance would lead to bio-debris build up inside the expressew shaft causing wear of internal components leading to rough deployment issues.However, it cannot be conclusively affirmed.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
|