Model Number N/A |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It is reported that upon incoming product inspection the product was found with a crease in the sealing area which could potentially compromise sterility.No adverse events were a result of this malfunction as there was no patient involvement.
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Manufacturer Narrative
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Review of the packaging determined that no failure was found as the products are within specification(s).No further investigation or action is required after review.The initial report was forwarded in error and should be voided.
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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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