Model Number N/A |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/22/2022 |
Event Type
malfunction
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Event Description
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It was reported that during set up prior to surgery dermatome handpiece was hard to connect to hose, it required more force to lock in place then should be necessary.Another device was used and the hose connected properly.No harm or delay were reported.No other adverse events were reported as it relates to this event.
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Manufacturer Narrative
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This incident has been recorded under (b)(4).Once investigation is completed a final/supplemental report will be submitted.
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Manufacturer Narrative
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This incident has been recorded under (b)(4).Review of the most recent repair record determined that the hose was hard to connect.The o-ring on the swivel and hose were replaced and resolved the reported issue 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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Event Description
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No additional information is available.
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Search Alerts/Recalls
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