Model Number N/A |
Device Problem
Difficult or Delayed Activation (2577)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/06/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-02868.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.
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Event Description
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It was reported that during the surgery, the anchor of this product was not set on the proper position completely and was about to came off from the tip of inserter when the nurse opened it.Therefore, the surgeon used an alternative one to complete surgery.No additional information available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was able to be confirmed by review of the returned juggerknot device (lot 473520).The anchor was frayed and the pusher was protruding through some of the strands.The second juggerknot was not returned as it was able to be implanted.Device history record (dhr) 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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