It was reported that during testing that the dermatome was not working.Device was not active during test.After evaluation, it was determined that the device exhibited inconsistent speed.There was no harm, injury, or delay as there was no patient involvement.Due diligence is complete.No additional information is available.No adverse event reported.
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This event is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the unit had low rpms and was out of calibration.The motor, bearing pack, o-ring, seal, reciprocating arm, lever, machine head, spring pin, e-ring, and widthplate screws were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.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.
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