H10: 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 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.This case reports, the suture anchor stripped out during implantation and reportedly required removal.The provided e-mail communication titled operative procedure in detail, does not support the reported failure mode which is the twixfix suture anchor stripped out while being implanted and had to be removed.It notes that a total of two 5 mm suture anchors, smith and nephew suture anchors were utilized and their position was confirmed under mini-c-arm fluoroscopy to be safe and appropriate position extraarticular.Once both suture anchors were appropriately tied down and the olecranon and triceps insertion were tightly apposed to each other, i then proceeded to use a 2-0 vicryl suture to repair fascia and soft tissue.The information provided via e-mail does not support or reference the reported suture anchor stripped out while being implanted.No patient injuries or adverse consequences were reported.It was noted via e-mail that the patient met all discharge criteria.Since no patient injuries are being 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 on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.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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