Catalog Number 3003940001 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source, foreign event occurred in(b)(6).Corrective action has been initiated for the reported issue.The device will not be returned to the manufacturer.Therefore it will not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.However, a corrective action has been initiated to address the reported 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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Event Description
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It has been reported that before the surgery the outer packaging of bone cement was complete, but there was leakage of powder and the inner sterile packaging is opened.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The device was not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.According to available data, the most probable root cause is due to packaging issue (sealing process).Corrective action has been initiated to address reported 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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Event Description
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It has been reported that before the surgery the outer packaging of bone cement was complete, but there was leakage of powder and the inner sterile packaging is opened.
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Search Alerts/Recalls
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