Catalog Number 829032170 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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.Product not returned.
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Event Description
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It was reported that an incoming inspector member found scratch on the sterile package.No further information was available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual inspection of the returned product identified a stress mark on the sterile package.The sterile barrier was still intact.The shrink wrap was not returned.The reported event is confirmed.Review of the device history records identified no deviations or anomalies.The likely condition of the product when leaving zimmer biomet was conforming to specifications.A definite root cause of the reported issue cannot be determined.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 is available at the time of this report.
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Search Alerts/Recalls
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