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 10/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Multiple reports have been submitted along with this report 0001825034-2021-03105, 0001825034-2021-03106, 0001825034-2021-03109.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.
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Event Description
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It was reported that the sterile package was damaged.No adverse events have been reported as a result of the malfunction and additional information on the reported event is unavailable.
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Manufacturer Narrative
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Visual evaluation of the returned product/photographs provided identified sterile packaging blister is damaged.Complaint sample was evaluated and the reported event was confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.The 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 and a packaging design issue.Corrective action has been previously raised to implement improved packaging changes.These packaging changes will reduce the number of transit related packaging damage events.Upon investigation, it has been determined that the debris in the sterile packaging meets the acceptable criteria and product is conforming to specifications.Event is no longer considered reportable, and initial report should be voided 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 further event information available at the time of this report.
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Search Alerts/Recalls
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