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 mitek or its employees that the report constitutes an admission that the device, 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.H10 additional narrative: h4: the device manufacture date was reported as unknown on the initial report; and has been updated accordingly.
|
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 mitek or its employees that the report constitutes an admission that the device, 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.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
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 mitek or its employees that the report constitutes an admission that the device, 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.H10 additional narrative: investigation summary: the complaint device was received and evaluated, upon visual inspection, the device showed a small amount of white lubricant on the tip which is less than the video shows.A manufacturing record evaluation was performed for the finished device m2104032 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.According with the visual inspection result, this complaint cannot be confirmed.A previous investigation with the manufacturer was performed, the outcome brought that there are controls in place related to the grease application.The outer tip grease, and in the line release, the quality inspector takes one piece during the shift or lot production and weight the grease of the inner/outer based on the quality work instruction, the results are documented.Also, there is 100% visual inspection during the process to review the final condition of the lubricant in the blade.On final inspection and cleaning process, a step of the inspection is to verify that there is no grease excess on the tip; this is an important control that avoid quality rejection.The possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure.During the installation of the blade, the operator may pulled the inner shaft out and inserted again, causing the lubricant to allocate at the tip.The video shows a greater amount of lubricant in the tip than what is seen in the physical device, this can be related to the handling of the device when is returned back, the tip was covered with a yellow fiber protection which is used for transportation, this fiber can absorb the lubricant, however, this cannot be conclusively determined.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.
|