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 11/17/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Event Description
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It was reported that during a surgery, the needle of the firstpass was broken.The trigger of the firstpass was not smooth when passing the suture to the tendon.The procedure was completed using a smith and nephew backup device; however, it is unknown if there was a delay.No further complications were reported.
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Event Description
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It was reported that during a shoulder arthroscopy, the needle of the firstpass broke into pieces outside of patient.The trigger of the firstpass was not smooth when passing the suture to the tendon.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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H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned in any original packaging.A needle cannot be seen through the bottom jaw window.Bio debris is present.There are no other visible defects.A functional evaluation showed pulling the lever will close and lock the jaw.Pulling the lever and trigger simultaneously will not deploy a suture passer needle.An analysis of the customer provided images found the box with the product information, the device laying on a surface, where it can be seen that the needle is missing, and the device with its trigger pressed showing the clamps closed and there is no needle.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.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include: (1) excessive force (2) tissue thickness.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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