It was reported that, outside of surgery on an unknown date, device not working.Repair tech observed rpms were in specification but erratic.The control bar was in the correct position.The calibration was out at the 0 reading.The head had considerable damage.No patient involved.No impact to patient and/ or user.Due diligence information in process.No additional information available.
|
This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the rpms were in specification but erratic, the control bar was in the correct position, the calibration was out at the 0 reading and the head was damaged.The motor, bearings, head, control bar, control shaft, control lever and other parts were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is confirmed.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.
|