Catalog Number 912082 |
Device Problem
Fracture (1260)
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Patient Problems
Failure of Implant (1924); Foreign Body In Patient (2687)
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Event Date 10/06/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.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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It was reported that during surgery, the tip of the anchor fractured and was retained by the patient.No other adverse consequences have been reported for this event.Attempts have been made and no further information has been provided.
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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.G2: user facility - this event is related to voluntary medwatch 3500 report# mw5114615.Please see attached for report.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the tip of the juggerknot mini is fractured and not all of the pieces were returned as the patient retained a foreign piece.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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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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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