Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/13/2021 |
Event Type
malfunction
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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.
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Event Description
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It was reported the tasp post broke upon disassembly of trials for cleaning after surgery.No product fell into the patient.The surgical technique was utilized and there was no surgical delay.
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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 returned product exhibits signs of repeated use and the anterior of the post feature has fractured off.All pieces were not returned.The device history records were reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found 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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