Model Number N/A |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/02/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The investigation is in process.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 the surgeon was using the juggerknotless for the first time.While deploying the anchor, with the knotless system, working the first part of the knot down through the cannula, it prematurely tightened and set.This caused the anchor to not set or deploy properly and could not be tightened to the labrum.The suture was cut and implant removed.
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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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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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