Model Number N/A |
Device Problems
Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/28/2018 |
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 follow up mdr will be submitted.
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Event Description
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It was reported that there was a loose particulate such as foreign substance which was found larger than 0.60 mm2.The issue was found at distributor inventory during inspection. no adverse events were reported as a result of this malfunction.
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Manufacturer Narrative
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Upon receipt of additional information, it has been determined that this device did not cause or contribute serious injury and has not been previously reported as a serious injury.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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