Model Number N/A |
Device Problems
Contamination /Decontamination Problem (2895); Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/06/2018 |
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.Expected, not yet received.
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Event Description
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It was reported that during incoming inspection at the warehouse, it was discovered that ten products were found to have the seal peeling off and a stain found on the product.Further, there were eight products that were found to have stains on the products only.There was no patient involvement.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Updated: complaint sample was evaluated and the reported event was confirmed.For passivation, the guide wires are placed on a rack with two or more contact points.These contact points cause a small portion of the guide wire to not receive a full passivation coating, leading to an inconsistent coating appearing as a "stain" or mark.These stains are not corrosion, and do not impact the fit, form, or function of the guidewires; they are merely cosmetic.Device analysis indicated that the device met specification.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 additional information received.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Corrected: remove device code "packaging problem" as it is no longer applicable for this complaint.
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Event Description
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It was reported that during incoming inspection at the warehouse, it was discovered that eighteen products were found to have a stain found on the product.There was no patient involvement.
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Search Alerts/Recalls
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