Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Code Available (3191)
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Event Date 05/14/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: 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.
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Event Description
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It was reported that during the surgery, the tip of the inserter was fractured and fell into the patient's body and was removed successfully.No additional patient consequences were reported.
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Manufacturer Narrative
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(b)(4).Reported event was considered confirmed as the inserter was returned with a fractured tip.Device history record was reviewed and no discrepancies relevant to the reported event were found.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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