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Model Number 72202674 |
Device Problem
Failure to Cut (2587)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2021 |
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 an arthroscopy using two fast-fix 360, when the knot pusher/ suture cutter was used, it did not cut the suture.The procedure was successfully completed without delay using a the same device, by forcibly pulling and cutting the suture.No patient injury or other complications were reported.
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Manufacturer Narrative
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Internal complaint reference (b)(4).The reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.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 review of risk management files found that the reported failure was documented appropriately.A visual inspection revealed the device was returned outside of original packaging.The inner shaft is coated in debris.No physical damage visible to device.A functional evaluation revealed the device cut suture as intended.The complaint was not verified 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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