Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/21/2021 |
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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00387.
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Event Description
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It was reported that broken instruments were found in a tray while prepping for a case.There was no patient involvement.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The returned tasp exhibits signs of repeated use (nicked or gouged) and anterior section of the post feature has fractured off.Not all pieces were returned.The dhr was 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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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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