Catalog Number 22-4038 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/27/2024 |
Event Type
malfunction
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Event Description
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It was reported that during an arthroscopy, the first pass suture passer got broken while being used.The procedure was completed with a surgical 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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H2: additional information on: b5, e1 & h6 (health effect - impact code).
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Event Description
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It was reported that during an arthroscopy, the first pass suture passer got broken while being used outside the patient.The procedure was completed with a surgical 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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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.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 precautions and warnings related to the use of the device.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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