Model Number N/A |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: foreign: country: (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 00819, 0001822565 - 2022 - 00820, 0001822565 - 2022 - 00821, and 0001822565 - 2022 - 00822.
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Event Description
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It was reported during the incoming inspection at zb warehouse in (b)(6) a team member found a packaging defect.Peeling in the sealing area.No patient involvement.No additional information.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed due to the review of photos.Visual review of the provided photo identified peeling in the seal area.Product was not returned, and therefore, no further evaluation can be performed.Device history record (dhr) was reviewed and no discrepancies were found.The condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the operator not following the work instructions provided.A corrective action has been previously initiated for the reported event.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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Upon reassessment of the reported event, it has been determined that the device sterility has not been compromised.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.Upon reassessment of the reported event, it has been determined that the device sterility has not been compromised.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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