Catalog Number 00236020527 |
Device Problem
Fracture (1260)
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Patient Problem
No Information (3190)
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Event Date 10/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).It is unknown if product will be returning to zimmer biomet and the investigation is in process.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 drill fractured during the procedure.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Report source - foreign - australia.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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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