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Model Number 72204048 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2022 |
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 when drilling the bone, the doctor removed the drill before activating the retrograde numbering, and the drill without the tip was noticed.X-ray was done and the drill was inside the bone.It is unknown if there was an excess force, but the material broke right at the tip.The same was removed from the patient, using the screw/screw technique.The procedure was completed with a significant delay using the same device.No further complications were reported.
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Event Description
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T was reported that during an arthroscopy when drilling the bone, the doctor removed the drill before activating the retrograde numbering, and the drill without the tip was noticed.X-ray was done and the drill was inside the bone.It is unknown if there was an excess force, but the material broke right at the tip.The same was removed from the patient, using the screw/screw technique.The procedure was completed with a significant delay using the screw/screw technique.No further complications were reported.
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Manufacturer Narrative
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H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were 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 risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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Search Alerts/Recalls
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