Catalog Number 414.502 |
Device Problem
Fracture (1260)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 08/04/2022 |
Event Type
Injury
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Event Description
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It was reported that during surgery, the tip of the cannula broke off in the femur and was retained by the patient.No other patient consequences were reported as a result of the event.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).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.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6.Visual examination of the returned device found it to exhibit signs of use nicked / gouged.The tip fractured off the tip wasn¿t returned, and has foreign material on the tip.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to use-error.Per the ifu and further review with development, exerting force on the cannula or knee during insertion can damage the cannula and surrounding bone.The users are not to attempt to bend or exert force on the cannula or joint while the accuport is inserted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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