Catalog Number 22-4038 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2021 |
Event Type
malfunction
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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 procedure, inside the patient the disp firstpass str passr self device did manage to deliver the first suture threw the cuff tissue.But on the second pass it got stuck and the needle did not get through the catcher.The procedure finished with a smith and nephew backup device.Surgical delay less than or equal to 30 minutes.Patient injuries were not reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection of the returned instrument shows no manufacturing abnormalities.No visual issues were observed.A functional evaluation revealed the needle and suture will deploy when trigger is initiated.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 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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