Occupation: initial reporter is a mitek sales representative.Investigation summary: despite multiple attempts made to the sales representative for the return of the complaint device, the device has not been received back for evaluation.This complaint cannot be confirmed.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.The lot number was not reported therefore a device history record (dhr) review could not be conducted.Also, a review into the depuy synthes mitek complaints system is not possible.We cannot discern a root cause for the reported failure mode.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.Device was used for treatment, not diagnosis.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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