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Catalog Number 7210499 |
Device Problem
Flaked (1246)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 12/15/2023 |
Event Type
Injury
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Event Description
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It was reported that during a shoulder arthroscopy, the full radius elite blade no longer worked properly and "flakes" were seen on the screen.An arthroscopic lavage was applied in the shoulder, and removed as much of the flake as possible, but residue was still present.The procedure was completed with a delay of less than 30 minutes using a smith and nephew back up device.No further complications were reported.
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Manufacturer Narrative
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H10: internal complaint reference number: (b)(4).
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Manufacturer Narrative
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H3, h6: the reported device was received for evaluation.A visual inspection revealed that the device was returned in original packaging with the batch number of the complaint on the label.The color scheme of the device matches the print.There are heavy scoring/grooves, in multiple areas, on the inner blade caused by debris caught between the inner and outer blade during use.This is scoring on the inside window of the outer blade from debris.The teeth on the blade are still sharp and bio debris is present.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.A clinical review states that due to the limited information provided, a clinical root cause of the reported flaking of the full radius elite blade cannot be determined.The patient impact is the blade residue remaining inside the patient.The blade is not intended for long term internal exposure, and long-term implantation data is not available.The patient impact is possible micro-motion and/or migration, and possible local irritation/discomfort.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include excessive side-loading and minimal irrigation.No containment or corrective actions are recommended at this time.
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Event Description
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It was reported that during a shoulder arthroscopy, the full radius elite blade no longer worked properly and "flakes" were seen on the screen.An arthroscopic lavage was applied in the shoulder, and removed as much of the flake as possible, but there were still metal pieces left inside the patient.The procedure was completed with a delay of less than 30 minutes using a smith and nephew back up device.No further complications were reported.
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Search Alerts/Recalls
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