Catalog Number 912076 |
Device Problems
Material Twisted/Bent (2981); Mechanical Jam (2983)
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Patient Problem
No Information (3190)
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Event Date 10/26/2020 |
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 report will be submitted.
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Event Description
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It was reported that the surgeon was unable to move the sleeve on the juggerknot.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.A juggerknot was returned for evaluation.A functional check of the sleeve was performed and was conforming to specifications.Visual examination of the returned product identified the tip to bent and it has likely happened during the surgery.Device history record was reviewed and no discrepancies were found.No failure was detected as the sleeve was working as intended.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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Search Alerts/Recalls
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