Catalog Number 407393 |
Device Problem
Fracture (1260)
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Patient Problem
No Information (3190)
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Event Date 05/31/2019 |
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.Product not returned.
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Event Description
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It was reported that during the surgery, while extracting the broach from the patient humerus, the distal part of the extractor broke.
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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.Udi: (b)(4).Report source : the event occurred in canada.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product noted the product has fractured at the tip in two different locations.A hardness check noted the product is conforming.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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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