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Model Number 7210751 |
Device Problem
Flaked (1246)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2021 |
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 arthroscopy, a blade 3.5mm elite full radius created metal flake.Procedure was resumed, after a non-significant delay (less or equal to 30min), with a back-up device.No further complications were reported.
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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 has debris on it.No physical damage is visible to the device.A functional evaluation of the returned device found that nothing is missing from device.Device was hooked up and powered up and nothing fell off.Device passed all functional test.A complaint history review found no 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.It has not been reported whether the metal flakes from a blade on a 3.5mm elite full radius were removed from inside of the patient.The root cause of the reported issue could not be determined.The patient impact beyond possible corrosion, local irritation/discomfort, and/or migration of the possible retained metal debris cannot be determined.It was reported the procedure completed without a significant delay or patient harm with a backup device.Since there were no other complications reported, no further clinical/medical assessment is warranted at this time.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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