Model Number N/A |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/27/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This user facility is outside of the united states.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: expiration date - ni.Manufacture date ¿ ni.Zimmer biomet (b)(4) and packaging supplier are in the process of initiating modifications to address reported issue.
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Event Description
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It was reported that when box of bone cement was opened, the inner package of powder was leaking into the outer packaging.There was no patient or procedure involvement.
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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.Corrective action has been initiated for the reported issue.(b)(4).
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Search Alerts/Recalls
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