Product complaint # (b)(4).
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Investigation summary: the complaint device was received at the service center and evaluated.
It was reported that the unit was not working properly.
The buttons were not working.
Per operational and diagnostic, the reported failure was confirmed.
A manufacturing record evaluation was performed for the finished device [1826m3741r] number, and no non-conformances were identified.
During evaluation, a short circuit was found in motor's cable, the cable was replaced.
Preventive o-rings replacement was performed.
The repair and testing of the unit was completed, bringing the unit back to full functionality.
The unit passed all functional tests and is fully operational.
The possible root cause for the reported failure was thus identified as lack of maintenance and normal wear.
At this time, no corrective action is required, and no further action is warranted, as the device was repaired and is fully functional.
However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.
Udi: (b)(4).
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