Model Number N/A |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/21/2019 |
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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The implant had the blister intact, but after opening it was verified that the inner container was damaged and not sterile.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Visual inspection of the returned packaging confirms that the inner sterile barrier (pouch) was damaged.The likely condition of the device when it left zimmer biomet was conforming to specification.The root cause of the reported event is likely to be transit damage.Device history record (dhr) was reviewed and no discrepancies were found.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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The implant had the blister intact, but after opening it was verified that the inner container was damaged and not sterile.
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Search Alerts/Recalls
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