Model Number N/A |
Device Problems
Leak/Splash (1354); Unsealed Device Packaging (1444)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 11/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).The product within this report is a combination product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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Event Description
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It was reported the inner sterile packaging was compromised, allowing the cement powder to leak out.No further information has been available at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.Investigation results concluded that the reported event was likely due to product design.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 the inner sterile sachet with powder was damaged, the powder was poured out.
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Search Alerts/Recalls
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