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Model Number 72204047 |
Device Problem
Firing Problem (4011)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2021 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that, during an arthroscopy procedure, the trunav drill was drilled over the guide pin, once the distal drill tip entered the joint and the blade was ready for deployment the blade would not deploy using the standard technique.The drill mechanism would not allow the blade to flip once inside the joint.The procedure was completed with a backup device and no significant delay or patient complication was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found the device was coated in debris.The distal drill tip had fractured from the device.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event excessive force placed on the device.
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Search Alerts/Recalls
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