This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial / final report based on information discovered during the device evaluation.Review of the most recent repair record determined the rpms were not in specification (low), the control bar was loose, and the calibration was out at the 0 and 10 readings.The motor, swivel, lever, eccentric shaft, reciprocating arm, and various other parts were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.The event is confirmed.A definitive root cause cannot be determined.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.
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It was reported that the handpiece has no power when the throttle phalange is pressed.The event occurred outside of surgery.There was no reported patient harm, or delay.At evaluation it was noted that the rpms were not in specification on the low end.Due diligence is complete, no further information is available at this time.
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