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Model Number 72204047 |
Device Problem
Break (1069)
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Patient Problems
No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/08/2020 |
Event Type
Injury
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Event Description
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It was reported that during an acl,pcl procedure, while using a 10.5mm competitor flip cutter it broke, therefore, an 10.5mm retrograde drill was used.While using the drill it was noticed that the blade was not fully seen and that the wire of the device was broken which caused that the blade was unable to be deployed.The procedure was successfully completed without significant delay using competitor device.No other complications were 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 was received for evaluation.It was determined the device contributed to the reported event.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection of the returned device found that it is not in its original packaging.The actuation wire is broken and not attached to the slider.There is debris on and in the drill.A functional evaluation of the device found that it would not deploy as intended due to the broken actuation wire per case details the blade was unable to be deployed.The procedure was completed using a different device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force during use, failure to retract the guidewire far enough back before attempting to deploy the blade, using the reverse function while drilling, attempting to deploy the blade while still inside the bone tunnel, or an impact event inconsistent with normal use.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.
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Search Alerts/Recalls
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