Catalog Number 912076 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Information (3190)
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Event Date 06/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
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Event Description
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It was reported that the sleeve was unable to be moved on the instrument.The surgeon was able to complete the surgery with another product with no impact to the patient.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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