Model Number N/A |
Device Problems
Difficult or Delayed Activation (2577); Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/02/2020 |
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 surgeon couldn't insert the anchor of jugger knot since the sleeve didn't slide at all during surgery.The surgery was completed with another device.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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Manufacturer Narrative
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Visual examination of the returned product identified that the tip was bent.The sleeve was depressed all the way to the handle.A function check could not be completed due to the tip being bent.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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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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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