Model Number N/A |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Information (3190)
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Event Date 08/28/2018 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint number - (b)(4).Udi # - (b)(4).Foreign source - (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.Expected, not yet returned.
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Event Description
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It was reported during the procedure, the preassembled locking screw was found to be stuck inside of the nail.Due to the event, there was a delay in procedure of approximately thirty-one to sixty minutes while the surgeon removed the initial product from the patient and implanted a new product.No additional patient consequences were reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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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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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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(b)(4).Reported event was considered confirmed from visual inspection and photos showing the threads are seized.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.(b)(4).
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Event Description
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No additional information received.
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Search Alerts/Recalls
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