Catalog Number 00597909526 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign source- (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation is completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the patella reamer blade would not assemble with the mating instrument.No adverse events have been reported as a result of the malfunction.
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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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Concomitant medical products: catalog# 00597909526 patella reamer blade with pilot hole lot# 63980089, catalog# 00512007026 patella reamer insetting guide with coating lot# ni.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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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Search Alerts/Recalls
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