Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/09/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Zimmer biomet complaint (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 tip of the instrument fractured during surgery.The broken piece of the instrument was removed and the surgical delay was no more than (5) five minutes.No adverse events have been reported as a result of the malfunction.
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Event Description
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This follow-up report is being submitted to relay additional information.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The complaint is confirmed.Visual evaluation showed signs of use as there was minor scratching on the body of the elevator and the tip had fractured off.The dhr was reviewed and there are no indications of a manufacturing defects and there are no updates to the risk documents needed.This is the only similar complaint for part# 09-0257, lot# 062818f18.The most likely underlying cause of the complaint is that excessive force was used, beyond what the instrument was designed to encounter.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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