This event is recorded by zimmer biomet under (b)(4).The following sections have been updated: b4, b5, d2, d4, d9, g1, g3, g6, h1, h2, h3, h4, h6, h10.Review of the most recent repair record determined the rpms were out of specification on the low end and the calibration was out at the 0 reading.Repair was declined and the device was returned to the customer.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.There was no event as the device was sent in for preventive maintenance only.It is confirmed the device needed repair.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|