Model Number N/A |
Device Problems
Device Packaging Compromised (2916); Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/24/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).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.If any further information is found which would change or alter any conclusions or information, a supplemental 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 that the package was found defective and foreign substance was found in on the inside of the package.
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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 device determined to be conforming to specifications.
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Event Description
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Upon examination of the returned device, it was discovered that there was no debris in the package.The device was confirmed to be conforming.
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Search Alerts/Recalls
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