Model Number N/A |
Device Problem
Device Stops Intermittently (1599)
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Patient Problem
No Information (3190)
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Event Date 12/04/2017 |
Event Type
malfunction
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Manufacturer Narrative
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B)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.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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It was reported that the knee instrument stopped during the use.The new instrument was opened to complete the case.
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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 sample was evaluated and the reported event was not confirmed.Evaluation of the returned patella reamer blade could not confirm any issue with it.The instrument does not bear any visual sign of damage.Dimensional analysis found that both the outer diameter and diameter of the central hole are conforming to print specifications.Device history record was reviewed and no discrepancies were found.The complaint was not confirmed, a definitive root cause cannot be determined with the information provided.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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