Model Number N/A |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: (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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-03269.Not returned.
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Event Description
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It was reported that the sleeve of the juggerknot mini was not retracting at impaction.The surgeon was unable to use the device.Attempts have been made and there is no further information at this time.
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Manufacturer Narrative
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(b)(4) reported event was confirmed as visual examination of the provided pictures identified that the tips of the devices are bent from use.No definitive statements can be made regarding the movement and function of the sleeves.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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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