Catalog Number 912082 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign - 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.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 approximately three (3) weeks ago during surgery, the plastic guide of juggerknotmini was stuck when operator try to push the anchor into the bone.The issue caused the anchor to not be deployed correctly into the bone.Surgery was completed with another device.Attempts have been made and no further information has been provided.
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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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Visual examination of the returned product identified the juggerknot mini was returned because the clear sleeve was stuck when the operator tried to push the anchor into the bone.The clear sleeve is fully deployed to the handle.The anchor was not returned.A function check of the juggerknot mini was done and is conforming.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.No device problem was found.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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