Catalog Number 3003940001-3 |
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 09/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign report source: (b)(6).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.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.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 during operation, the cement powder packet was found not sealed properly, and the powder has leaked inside the packaging.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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(b)(4).The product analysis shows that on the inner pouch, the right sealing is opened on all the length.The reported event is confirmed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.(b)(4) complaint has been recorded on refobacin bone cement r 1x40-3, reference (b)(4), over the batch a930ca0806.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 during operation, the cement powder packet was found not sealed properly, and the powder has leaked inside the packaging.No adverse events have been reported as a result of the malfunction.
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Search Alerts/Recalls
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