Model Number N/A |
Device Problems
Calibration Problem (2890); Material Deformation (2976); Naturally Worn (2988)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2022 |
Event Type
malfunction
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Event Description
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It was reported the dermatome was sent in for maintenance and found to have worn screws, needed calibration, and had damaged width plates.No harm or delay were noted with this event.No other adverse events were reported.
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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 completed, a follow-up/final report will be submitted.
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Event Description
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No additional information is available.
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Manufacturer Narrative
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This complaint has been recorded under (b)(4).Review of the most recent repair record determined that the widthplate screws were worn and the unit was out of calibration.The widthplate screws, shaft bearings, and sleeve bearings were replaced and resolved the reported issue.Additionally, during inspection the 4-inch widthplate was found to be damaged.The 4-inch widthplate was returned unrepaired.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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Search Alerts/Recalls
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