This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g4, g7, h2, h3, h6, h7, h9, h10.The product was evaluated through manufacturing review, however, the reported event was unable to be confirmed.The device history records were reviewed and no discrepancies were identified.A corrective and preventative action investigation into this issue was initiated to recommend against using ultrasonic cleaning as a sterilizing technique for these devices.The device was subsequently re-designed to account for this failure mode with a new locking mechanism.This device was manufactured prior to the design modification and therefore the root cause is the previously addressed design issue.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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