Model Number N/A |
Device Problem
Failure to Cut (2587)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete 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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It was reported that during surgery the device was cutting too deep into the patient.There was impact to the patient, but no further details have been provided.The surgeon was not happy with the depth.Due diligence is in progress.No further information is available at this time.No adverse events were reported as a result of this malfunction.
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Manufacturer Narrative
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Review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.The event cannot be confirmed.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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There is no additional event information available.
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Search Alerts/Recalls
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