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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Udi: (b)(4).
A manufacturing record evaluation was performed for the finished device [m1910006] number, and no non-conformance's were identified.
As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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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 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.
Investigation summary: according to the investigation provided, it was reported that during unknown procedure, metallic debris was noted at the beginning of surgery when activating three 4 mm agressive blade plus.
The device was received and evaluated in juarez lab.
It was observed that the tip between the outer and inner had slightly marks of wear.
Also, it was received in its original packaging.
The devices were sent to r&d for further investigation.
The investigation began with having the operations team investigated the manufacturing facility where the blades are made and to review dhr¿s for obvious deviations or anomalies.
The operations team concluded that there were no obvious deviations to be concerned with.
The investigation was divided into three stages, complaint blade inspection, spring force testing, o-ring testing.
Since there were signs of wear and discoloration detected on the blades, the team decided to randomly select complaint blades to be inspected for out of specification tolerances.
A doe was constructed to test the three factors to see which have the largest effect on shedding.
A tolerance analysis was conducted on the handpiece with blade assembly to find the maximum and minimum values for the gap where an acceptable amount of shedding is allowed.
The test was conducted following the shed test method using eight blades alternating the following parameters: material type, speed, and spring force.
In conclusion, the results show that the factor direction is above the specification, therefore it has the largest effect on shaver shedding of the three factors.
Although factor of spring force is below the mark it was investigated since it is a factor that can be controlled while direction is based on surgeon discretion.
The results conclude that the material does not have a significant effect on the shedding and that a higher amount of shedding occurs when the spring force is increased, and the shaver blade is run at higher speeds (
=
6,000 rpm).
Also, a sample was ran for 30 seconds, sample two was ran for 60 seconds, and sample three was ran for 60 seconds.
The test results concluded that if there is a significant amount of shedding it will occur in the first 30 seconds and not gradually over time.
In addition, after discovering that some handpieces were missing the o-ring in the front of the handpiece, a test was conducted to determine how this could affect shedding.
As seen in the results shedding can be reproduced, but with the o-ring present and proper spring force maintained, the amount of shedding is significantly decreased.
A manufacturing record evaluation was performed for the finished device [m1910006] number, and no non-conformances were identified.
Based on the investigation potential ways to reduce shedding is to ensure all handpieces are properly serviced and maintained to ensure the presence of the o-ring.
During the servicing make sure tissue seal spring is properly placed and that no debris is caught on or under the tissue seal spring, which could cause an increase in the spring force.
Continue to monitor and inspect the handpiece usage in the region and verify that the decontamination and cleaning processes are following the proper ifu.
Another potential way to reduce shedding is to run the blades at a lower speed and in oscillation direction as shown in the test results.
As this complaint rate falls within the expected occurrence rate per the dfmea, no further risk reduction actions are required.
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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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.
A manufacturing record evaluation was performed for the finished device [m1910006] number, and no non-conformances were identified.
D10, 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.
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