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Model Number N/A |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problems
No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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: 0001825034 - 2021 - 00437, 0001825034 - 2021 - 00438, 0001825034 - 2021 - 00440.
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Event Description
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It was reported during investigation of products at the distributorship, that the sterile packages were damaged.There was no patient involvement.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was returned and evaluated.Visual inspection identified damage to the sterile blister and debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging.Sterility has not been compromised.Dhr was reviewed and no discrepancies were found.The likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event can be attributed to transit damage.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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Search Alerts/Recalls
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