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 06/22/2016 |
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.The following sections could not be completed with the limited information provided.Zimmer biomet (b)(4) and package supplier are in the process of initiating modifications.Product location unknown.
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Event Description
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It was reported that when box of bone cement was opened, the 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.Udi - (b)(4).Product return date - ni.(b)(4).Corrective action has been initiated for the reported issue.
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Search Alerts/Recalls
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