Model Number N/A |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/25/2022 |
Event Type
malfunction
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Event Description
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It was reported that cover of the housings opened during surgery.There was no harm or injury to patient reported.This event is related to a malfunction that could potentially lead to a sterility issue.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Manufacturer Narrative
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(b)(4).The device was not returned for complaint investigation.The device could not be visually inspected in an effort to confirm the defect.Dhr review was performed.Device was 14 months old and is not out of box failure.Device is used for treatment.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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