Catalog Number 20123605 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/26/2023 |
Event Type
malfunction
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Event Description
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It was reported that during the procedure, debris was found on the liner.Another liner was used to complete the procedure.There was no harm or health consequences to the patient.Attempts have been made and no furhter information is available at this time.
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Visual evaluation of the provided photo found debris on the liner.The sterile packaging has been opened.As the sterile packaging has been previously opened, the source of the debris cannot be confirmed.The complaint cannot be confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause or condition of the device when it left zimmer biomet cannot be determined, as the product has been opened.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 additional event information to report at this time.
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Search Alerts/Recalls
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