Catalog Number 405900 |
Device Problem
Fracture (1260)
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Patient Problem
No Information (3190)
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Event Date 08/22/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign: (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.Product not returned.
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Event Description
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It was reported that the instrument fractured during the procedure.There was no delay or impact to the patient.Attempts have been made, and no further information has been provided.
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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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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified the black plastic impactor had fractured.There was impact damage to the strike plate and wear to the shaft of the device.Device history record was reviewed and no discrepancies were found.Root cause could not 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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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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