Model Number N/A |
Device Problems
Leak/Splash (1354); Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/14/2017 |
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.Other not returned to manufacturer.
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Event Description
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It was reported the cement inner sterile packaging was ripped, allowing the cement powder to pour out.No patient consequences or additional information were reported.
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Manufacturer Narrative
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(b)(4).Complaint sample was evaluated and the reported event was confirmed.Evaluation of returned device found the supplier sealing was opened in 2 areas.The manufacture sealing was intact.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to product design issue.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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Please refer to report 3006946279-2017-00278.
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Search Alerts/Recalls
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