Model Number N/A |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product has been received by zimmer biomet and 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 sterility of the stems package has been compromised.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No additional information on the reported event.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual evaluation of the returned product/photographs provided identified sterile packaging pouch is damaged.The reported event is confirmed; sterility has not been breached.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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.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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