(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b5, d5, d10, g1-2, g4, h2, h3, h6, h8, h10.Complaint sample was evaluated and the reported event was confirmed.The product analysis shows that the handle doesn¿t come in the correct position.It must be pushed to come in the correct position.The review of the device manufacturing quality record indicates that (b)(4) products designation optigun ratchet, reference 4195, lot number 0209860012 were manufactured on 03 february 2015.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 similar complaint has been recorded for optigun ratchet, reference 4195, batch 0209860012 within one year.The probable root cause is the wear of the product and the fouling inside the optigun.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.The product analysis shows that the handle doesn¿t come in the correct position.The probable cause is the wear of the optigun.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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