Model Number N/A |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/25/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.G2: foreign: uk.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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It was reported dermatome blade has a curve in the middle section of the blade.Blade lot isolated from patient usage.Blades measured using engineering square.Middle of blade curve apparent.Inverting the blade 180 deg causes corners to bow upwards.There was no harm or delay reported.No adverse events were reported as a result of this malfunction, due diligence is in progress and there is no additional event information till date.
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Event Description
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There is no additional event information.
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Manufacturer Narrative
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No product was returned, or pictures provided; functional, visual, and/or dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to a manufacturing issue.The event cannot be 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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