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 05/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(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.Product not returned.
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Event Description
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It was reported that the cutter did not cut cable.The cable frayed.No patient involvement, event reported during inspection at the distributor.No further event information is available at the time of this report.
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Manufacturer Narrative
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Udi# (b)(4).Visual examination of the returned product identified that the jaws did not close all the way.Functional check was made and the cutter did not cut the wire completely.The device history records were reviewed for deviations and/or anomalies with the following related anomalies/deviations identified: 12 pieces are scrapped due to jaws not cutting the cable.Root cause was unable to be determined.Further actions have been indicated through capa process to investigation this issue.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 is available at the time of this report.
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Search Alerts/Recalls
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