Model Number N/A |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for the 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 -01024.0001825034 -2021 -01025.0001825034 -2021 -01026.0001825034 -2021 -01027.
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Event Description
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It was reported that during stock investigation, the sterile packages were found to be damaged.It is unknown if the damage has breached the sterile barrier.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d9; g3; h2; h3; h6.Complaint sample was returned and evaluated against the reported event.Visual evaluation of the returned product/provided photos identified damage to sterile blister with 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 the product 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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Event Description
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No additional event information to report at this time.
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Search Alerts/Recalls
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