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Model Number 7205305 |
Device Problems
Overheating of Device (1437); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference case-(b)(4).
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Event Description
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It was reported that, during acl reconstruction procedure, the full radius blade 3.5mm disp presented a "blade stall" error message when connected to the handpiece and it was overheating.Procedure was resumed, without any delay, with a back-up device.Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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H10: h3, h6: the reported device was received for evaluation.There was no relationship found between the device and the reported event.A visual inspection revealed the device was not returned with original packaging and the device looks like it has debris on it, possibility of lubricant.No other physical damage is visible to the device.A functional evaluation of the returned device found that device is in working order, device did not stall or overheat.Device passed all functional test.Device functioned as per manufacture spec.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.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.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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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