Model Number 321.02.346 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/02/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) initial report.The reported devices are being returned to corin and will be examined.Details of this review will be provided in a supplemental report upon completion of the investigation.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.Please note: this report is filed with the fda due to an event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
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Event Description
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During surgery once the trinity acetabular shell was impacted in the acetabulum, it could not be detached from the trinity introducer handle.The impacted shell was removed and alternatives used.This caused a delay to surgery of more than 30 minutes.
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Event Description
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During surgery once the trinity acetabular shell was impacted in the acetabulum, it could not be detached from the trinity introducer handle.The impacted shell was removed and alternatives used.This caused a delay to surgery of more than 30 minutes.
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Manufacturer Narrative
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Per -5767 final report.The reported trinity introducer handle and trinity acetabular shell were returned for examination.The failure mode was confirmed, however, after a few impactions the shell could be removed from the handle.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.Based on the available information, the root cause of the event could not be determined.However, trending has identified that this could be a user issue.Corin will continue to monitor trends relating to this or similar failure modes and this case is now considered closed.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
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Search Alerts/Recalls
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