Next generation device was released in August 2007. We are still receiving back used devices, which failed during a procedure and require investigations. The devices coming back have Lot Numbers (from the old generation devices) that have already surpassed the shelf life (expired).
Why is it taking so long for you to recieve the failed devices back?, there is a clause 820.198 (a) (1) ...All complaints shall be processed in a uniform and
timely manner... It appears your shelf life is short therefore the mechanism/process for returns should be investigated.
Per FDA guideline, do we as a device manufacturer still have to perform thorough investigations on those "used" expired products or can we just create a one-page letter stating that since the shelf life has expired, it will be redundant to perform a thorough investigation.
820.198 (c) ...
Any complaint involving the possible failure of of a device... to meet any of its specifications shall be reviewed, evaluated
and investigated, unless such investigation already been performed for similar...
You have stated that the next generation "should" correct the failure mode, I would be more assertive here it either does or does not, if it does how do you know, what I am driving at is, if you were aware of the problem and have already investigated and corrected, this may cover this clause, I say may because I do not know all the details and have not seen what work was done to produce next generation... I would get your QA and RA group to look closely at this.
In answer to your your question "thorough investigation" I have one of my own
Was this a reportable event i.e. FDA part 803?
IMHO what this hinges on is the work that was done for next generation, and what you are doing to address the lateness of customer returns