Model Number N/A |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product has been returned to zimmer biomet and the investigation is currently in process.Once the investigation has been completed, a follow up report will be submitted.
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Event Description
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It was reported that after broaching, the stem sat proud.The surgeon indicated the broach was dull and a larger size broach was used to complete the procedure.There was no reported patient injury or significant delay as a result of the event.Attempts have been made and no additional information is available.
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Manufacturer Narrative
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Complaint sample was evaluated and the reported event could not be verified.Visual inspection of the devices shows the cutting edges are dull and damaged.All returned rasps were evaluated using their respective overlay that measures size specifications except for some cutting edges fell under the tolerance zone due to damage and/or dullness.Hardness readings measured conforming to print specification.Device history record (dhr) was reviewed and no discrepancies were found relevant to the reported event.Root cause of the event could not 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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