Model Number 921.036 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/13/2023 |
Event Type
malfunction
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Event Description
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During surgery, whilst impacting the trinity ecima liner, the liner impactor head broke.Broken parts of the liner impactor head were retrieved from the joint space and there was no reported patient impact or delay to surgery.
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Manufacturer Narrative
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Case (b)(4), initial report.Additional information including; was the impactor aligned correctly before impaction, was a crack notices on the impactor prior to impaction and how is the patient doing post operation has been requested and if received, 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 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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Manufacturer Narrative
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(b)(4) final report.Additional information including; whether the impactor was aligned correctly before impaction, were any cracks noticed on the impactor head prior to impaction and an update on the patient post-op was requested in order to aid the investigation.The reporter confirmed that the impactor head was aligned and screwed on correctly and that the crack was identified after use.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.It was found that this device was manufactured in jun 2022 as part of a batch of 28 and conformed to material and dimensional specification at the time of manufacture.The device was not returned to corin uk, however, a photograph was provided which confirmed the reported failure.This failure has been reported to corin previously and corrective actions are currently being implemented to improve the durability of the device.Therefore, 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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