Catalog Number 110024773 |
Device Problems
Difficult or Delayed Activation (2577); Difficult or Delayed Separation (4044)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/23/2023 |
Event Type
malfunction
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Event Description
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It was reported that the anchor didn¿t deploy during a procedure.No harm or impact to the patient was reported.Attempts have been made and no additional information on the reported event is available at this time.
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Manufacturer Narrative
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(b)(4).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.Zimmer biomet will continue to monitor for trends.Associated products: item#110024772; lot#466980.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Event Description
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Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report 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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