Model Number N/A |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(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 a snapshot mini open kit was opened and the seal on the package was stuck together calling into question its sterility.
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Manufacturer Narrative
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(b)(4).Upon receipt of the investigation it has been determined that this device did not cause or contribute to the reported event.It was found that the seal area found no other areas of concern.Seal is intact and sterility has not been compromised, in which case there is not previously reported issues.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported event can be attributed to the operator not following instructions during manufacturing.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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Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.
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Search Alerts/Recalls
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