Model Number N/A |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).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 clear sleeve of the juggernaut could not slide smoothly during a procedure.Attempts have been made and additional information on the reported event is unavailable.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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This follow-up report is being submitted to relay additional information.The complaint sample was evaluated and the reported event was not confirmed.Visual examination of the returned product noted no apparent damage and the anchor is still assembled to the tip of the inserter.The function check was conforming and the device works as intended.Device history record was reviewed and no discrepancies were found.Device analysis indicated that the device met 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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Search Alerts/Recalls
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