Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).The product has been returned to zimmer biomet for evaluation.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 tip fractured on a pair of wire cutters.The malfunction was discovered during cleaning.No adverse events were reported as a result of this 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.A visual inspection was performed on the product and a small chip could be seen in one of the cutter blades.The dhr was reviewed and there were no non-conformances found.There are no indications of manufacturing defects.This is the only complaint in regards to the tip fracturing for 51-0928 lot 071317g17.For this part (51-0928) and the previous one year (from the notification date) regarding the tip fracturing, (b)(4).The most likely underlying cause is excessive force being applied to the tip that was more than the product is designed for.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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