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 08/02/2023 |
Event Type
malfunction
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Event Description
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It was reported by the distributorship that the products were found to be nonconforming.Our incoming inspection team member found hair like debris in the sterile package.The 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 is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial report.E1 phone:(b)(6).G2: japan.Related reports: 0001526350-2023-00997.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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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Visual inspection confirmed there was debris inside 2 of the sealed packages.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.As the product was conforming, a root cause cannot be determined.The debris was confirmed; however, the product is conforming.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.Multiple mdr reports were filed for this event, please see associated report: 0001526350-2023-00997-1.
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Event Description
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There is no additional information available.
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Search Alerts/Recalls
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