Model Number N/A |
Device Problems
Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial report.E1: phone: (b)(6).G2: foreign: finland.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.H3 other text: device not yet returned.
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Event Description
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It was reported that inside the pulsavac package, white "fluff"/small crumbs were found.Event occurred outside of surgery.There was no reported patient harm, or delay.Due diligence is complete, no further information is available at this time.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).The device was returned opened but unused.Visual inspection confirmed there was white particulate present on the device tubing.As the seal was opened it cannot be confirmed if the device left zb control with the particulate in the packaging.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event cannot be confirmed as the packaging was returned opened.If any further information is found 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 additional event information.
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Search Alerts/Recalls
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