(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b5, d10, e1, g4, h2, h3, h4, h6, h8, h10.Complaint sample was evaluated and the reported event was confirmed.The returned device evaluation shows that the product it seemed to be in good condition in terms of appearance.However, it was noted on the handle that there was a piece of spring coming out of the handle.We also noticed that there was missing a pin supposed to hold the spring to make the optigun work as intended.The pin is not there so the optigun does not work.The review of the device manufacturing quality record indicates that (b)(4) products designation optigun ii, reference (b)(4), lot number 690633012 were manufactured on 06 march 2019.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.No other complaint on the issue has been recorded for optigun ii, reference (b)(4), lot number 690633012 within one year.An investigation has been performed, consisting of a documentary review and a product analysis.The documentary review showed that products were manufactured according to the pre-defined specifications of biomet france.According to available data, the exact root cause of the event can¿t be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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