If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: the device was received and evaluated.When performing the visual inspection, the second device "revelated" that the first implant was deployed.The functional test was performed; the second implant was deployed as intended.A manufacturing record evaluation was performed for the finished device 8l09441 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the implants condition, this complaint can be confirmed.The possible root cause for this issue can be attributed to the handling of the device, the operator did not squeezed the red trigger to its fully position.As per ifu, at desired depth, fully squeeze the red deployment trigger while maintaining depth positioning to deliver the first implant.The implant is fully deployed when you hear an audible ¿click¿.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
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