Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/15/2017 |
Event Type
malfunction
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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.
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Event Description
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It was reported that the provisional was fractured during routine use.No adverse events have been reported as a result of this malfunction.Attempts have been made and additional information on the reported event is unavailable.
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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: complaint product was evaluated and the reported event was confirmed.Dhr was reviewed and no discrepancies were found.Investigation results concluded that wear and tear are the root causes of the reported instrument failure.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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