Catalog Number 72290128 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/15/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H10: internal complaint reference number: (b)(4).
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Event Description
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It was reported that during an arcr procedure, when the package was opened and before the firstpass mini was inserted into the joint, the one-side capture window fell off.The procedure was completed without surgical delay using a smith and nephew back up device.No further complications were reported.
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Manufacturer Narrative
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Internal complaint reference case (b)(4).The reported device was received for evaluation.A visual evaluation showed the device was not returned in original packaging.One side of the suture capture has been disconnected from the upper jaw.The returned suture capture piece is not deformed.No other visual deficiencies.A functional evaluation showed pulling the lever will close the jaw and deploy the suture passer needle but cannot capture the suture due to the broken capture.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 was associated with unintended use of the device.Factors that could have contributed to the reported event include: excessive force, tissue thickness or damage or debris on the device tip between passes.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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