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 09/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The product will not be returned to zimmer biomet for the investigation as the device remains implanted.The investigation is in process.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 packaging of a device was being questioned for possible sterility issue.The implant was ultimately used without confirming if the sterility had been breached.There was no reported harm or injury to the patient.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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is being investigated as a manufacturing related 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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No additional event information to report at this time.
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Search Alerts/Recalls
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