Model Number N/A |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/02/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: event occurred in (b)(6).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 cable cutter does not cut the cable properly.Cutting surfaces are not sharp enough.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The returned device was functionally tested and it was able to cut the cable under tension as expected without any issues.No failure detected, as the device operated within specifications.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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