Catalog Number 231200101 |
Device Problem
Fracture (1260)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 04/21/2020 |
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 report will be submitted.
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Event Description
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It was reported that the instrument fractured in the screw.The piece was retained by the patient and there are no plans to remove it.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Upon visual inspection the device tip has been fractured there is no further damage to the device.The device has approx.3 years of field service age and it is unknown how many times the device is used.Device history record was reviewed and no discrepancies 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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