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: according to the information provided, it was reported that the device was leaking.The complaint device was received at the service center and evaluated.Per service manual operational and diagnostic, the reported failure was not confirmed.During evaluation, the reported issue cannot be duplicated.Additionally, no other fault was found.The testing of the unit was completed per the service manual, the unit passed all functional tests and is fully operational.The possible root cause for the reported failure cannot be determined.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.At this time, no corrective action is required, and no further action is warranted, as the device 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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