Model Number N/A |
Device Problems
Device Packaging Compromised (2916); Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).Reporter had indicated that product will be returned.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 the sterile packaging of the device fractured.This was discovered before delivery to the hospital.No patient involvement.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated.Reported event is confirmed by review of actual packaging/device received.Device history record (dhr) was reviewed with one deviation identified: (b)(4) was created at (b)(4); 1 part was scrapped for a casting defect.All other parts were accepted.This ncr is not related to the reported event.The likely condition of the product when it left zimmer biomet was conforming to all specifications.However, specific root cause cannot be determined.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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