Model Number N/A |
Device Problems
Failure to Cut (2587); Calibration Problem (2890); Material Split, Cut or Torn (4008)
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Patient Problems
Abrasion (1689); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2022 |
Event Type
Injury
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Manufacturer Narrative
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This event is recorded by zimmer biomet under (b)(4).The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
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Event Description
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It was reported that during a procedure the device was not cutting properly which resulted in the patient being subjected to an additional hour of medical/surgical intervention in order to make thinner cuts to accomplish the graft.Due diligence is complete and there is no further information available.
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Manufacturer Narrative
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This event is recorded by zimmer biomet under (b)(4).Review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.Based on the pictures provided, no determinations can be made on the condition of the product or what contributed to the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.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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No additional information is available regarding the incident.
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Search Alerts/Recalls
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