Model Number N/A |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Udi #: (b)(4).Foreign county: (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 was reported that incoming inspection member found hair like substance in the sterile package.
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Manufacturer Narrative
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Reported event was confirmed with the device returned and visual inspection performed.An unknown hair-like debris within the sealed sterile cavity was identified.Review of the device history records identified no relevant deviations or anomalies.The root-cause of the reported event is the operator not following instructions during the manufacturing process.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 further event information available at the time of this report.
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Search Alerts/Recalls
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