Model Number 89-8521-470-40 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign source: united kingdom.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that the aseptic battery housing opened during surgery.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, whatever additional information received has been included in this report.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Dhr review was performed.Device was 8 months old and is not out of box failure.The device was not returned for repair/evaluation.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 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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