It was reported that during a shoulder scope arthroplasty, when the firstpass was opened, it was noticed that the tip (jaw) was broken off.The procedure was completed with a delay of roughly 2 minutes using a smith and nephew back up device.No further complications were reported.
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H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned in any original packaging.The suture capture has been broken from the upper jaw but not returned.Bio debris is present.A functional evaluation revealed the jaw will close and the suture passer will deploy when trigger is initiated.These failures have been determined to be related to the reported event.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 an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
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