Model Number N/A |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Information (3190)
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Event Date 08/25/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr's were submitted for this event.Please see reports: 0001822565-2017- 06570 ,0001822565-2017-06571.(b)(4).Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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Event Description
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It was reported that foreign debris was found inside the sterile barrier.Surgery was delayed for 31-60 minutes.No further information has been made available at this time.
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Manufacturer Narrative
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Reported event was confirmed by review of the provided photo.Form the received photos, it was determined that the polybag has the black stain.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.The root cause can be design deficiency and 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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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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Search Alerts/Recalls
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