SMITH & NEPHEW, INC. CL-TR THRD CANN 8MM/76MM LTX FREE (10) G; ACCESSORIES,ARTHROSCOPIC
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Model Number 014718 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2022 |
Event Type
Injury
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Event Description
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It was reported that during a shoulder arthroscopy, the seal of a 'clear-trac threaded cannula' was difficult to put instruments through.Toward the end of the case, a piece of the seal was seen in the shoulder joint space.The piece was removed from the patient with an arthroscopic grasper.Surgery was resumed, after a non-significant delay, with the same device.No further complications were reported.
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Manufacturer Narrative
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Internal complaint reference: case (b)(4).
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Manufacturer Narrative
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Internal complaint reference (b)(4).H10 h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported event.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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Based on the information provided, the broken piece of the seal was removed from inside of the patient.According to the report, the surgery was completed by the surgeon with a non-significant surgical delay using the same device.Since there were no patient complications reported, no further clinical/medical assessment is warranted at this time.The complaint was not confirmed.Factors that could have contributed to the reported event include excessive force, off-axis insertion of sharp instruments, or fatigue on the seal from insertion and removal.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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Manufacturer Narrative
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H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Based on the information provided, the broken piece of the seal was removed from inside of the patient.According to the report, the surgery was completed by the surgeon with a non-significant surgical delay using the same device.Since there were no patient complications reported, no further clinical/medical assessment is warranted at this time.Though the device was not returned for evaluation the reported failure has been associated with an insufficient design.A corrective action was generated to address this failure and subsequently the design changed in order to prevent the adhesion of the incision.
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