Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Foreign Body In Patient (2687)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Date of event - unknown date, (b)(6) 2018.Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report was received via a user facility report.Please reference attached.(b)(4).
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Event Description
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It was reported that during an open reduction internal fixation of the left humerus, the k-wire fractured.The surgeon left the broken piece in the bone, as he felt that it would cause more damage to try and remove it.No additional patient consequences have been reported.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The product could not be evaluated and the reported event could not be confirmed.The device history records could not be reviewed as the lot number of the device involved in the event is unknown.A definitive root cause could not be determined with the information 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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