Model Number N/A |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/03/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.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 vacuumed sealed sterile package had a hole in the plastic, another device was used for the procedure.
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Manufacturer Narrative
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(b)(4).The reported event (damaged outer barrier) has been confirmed through visual inspection of photographs provided, which confirms the inner sterile barrier (pouch) is damaged.Device history record (dhr) was reviewed and no discrepancies were found.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 the transit damage.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 was reported that the vacuumed sealed sterile package had a hole in the plastic, another device was used for the procedure.
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Search Alerts/Recalls
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