Model Number N/A |
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 06/20/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This user facility is outside of the united states.The necessary manufacturing history to review was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Zimmer biomet (b)(4) and package supplier are in the process of initiating modifications.
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Event Description
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It was reported that when box of bone cement was opened, package of powder was leaking.There was no patient involvement and no delay in a procedure as a result of the event.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.An investigation of the complaint has been performed consisting of a documentary review.The review of manufacturing dhr shows that products were manufactured according to the pre-defined specifications.According to the available data and as the product has not been returned for inspection, the exact root cause of the incident cannot be determined.(b)(4).
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Search Alerts/Recalls
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