Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign report source: (b)(6).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.
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Event Description
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It was reported that the instrument fell apart while setting up a drill guide pre-op.The push trigger on the back of the handle backed out when being used.No patient involvement.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) 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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