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 10/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source, foreign - event occurred in (b)(6).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.
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Event Description
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It has been reported that during the surgery, the bone cement was found the outer packing of the bone cement was normal and intact, but the top sealing of the internal sterilization package was opened before surgery.
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Manufacturer Narrative
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(b)(4).The following sections were updated:d4-d5-e1-g1-2-g4-h2-h6-h10 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 was been reported that during the surgery, it was found that the outer packaging of the bone cement was normal and intact, but the top sealing of the internal sterile package was opened.The product was not used.No adverse event was reported.
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Search Alerts/Recalls
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