Model Number N/A |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/27/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source, foreign - the event occurred in (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the package was found defective.There was a crease in the sealing area that compromised sterility.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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Upon receiving additional information on the reported event, it was determined to be not reportable as visual inspection of the returned sealed pouch determined to be conforming to specifications.
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Search Alerts/Recalls
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