Catalog Number 00515047500 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).G2 foreign: (b)(6).Evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed.
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Event Description
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It was reported that at unknown timing on (b)(6), 2023 a hair-like foreign substance was found inside the sterilization tray but not on the device itself.There was no harm, injury or delay reported.Due diligence is complete; no additional information.No adverse events were reported as a result of this malfunction.
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Event Description
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No additional information is available regarding the incident.
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Manufacturer Narrative
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This event is recorded by zimmer biomet under (b)(4).The product was returned opened, but unused, in the original tyvek tray.Visual inspection confirmed there was a long, hair-like debris on the product tubing.It cannot be confirmed if the device was non-conforming as the packaging was returned open.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event cannot be confirmed.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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Search Alerts/Recalls
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