Model Number N/A |
Device Problems
Unstable (1667); Calibration Problem (2890); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that the air dermatome does not work.There is a cut in the hose.The motor rpms were in specification but erratic and was out of calibration.No harm or delay reported.Due diligence is complete and no additional information is available.No adverse events were reported as a result of this malfunction.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Once the investigation is complete, a follow up/final report will be submitted.
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Event Description
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No additional event information available.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record determined the motor speeds were within specification but erratic and the device was out of calibration at the 0 reading.The swivel, hose, motor, eccentric shaft, bearing, gear, spring seal, and various other parts were replaced and the device was recalibrated 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.
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Manufacturer Narrative
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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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Event Description
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There is no additional event information available.
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Search Alerts/Recalls
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