Additional narrative: conclusion and justification status: the complaint states attune spacer block discovered broken in spd.The investigation confirmed the failure mode as reported.The device was reviewed by bioengineering and a report was received stating; investigation of the returned device confirms the complaint; the post of the attune spacer block has broken off.It should be noted that not all pieces have been returned, however the original complaint form states all pieces were removed from the patient.As there are a number of potential root causes that may result in this damage; the cause of the failure is unknown.Design review (b)(4) was completed in august 2016 which investigated possible design solutions to balseal post cracking.It was concluded that no design improvements, protective measures or information for safety could be implemented that would definitely reduce the risks without increasing or adding risks.The q1 2016 pms report ((b)(4)) identifies no safety signals and concludes no follow up actions are required for the attune spacer block.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per (b)(4).
|