Model Number N/A |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 10/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that before surgery, the doctor opened the bone cement and found that the powder was leaking out and the aseptic packing bag was not sealed.
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Manufacturer Narrative
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(b)(4).The following sections were updated: d4-d5-d10-g1-2-g4-h2-h4-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 reported that before surgery, the doctor opened the bone cement and found that the powder was leaking out and the aseptic packing bag was not sealed.
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Search Alerts/Recalls
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