H10: h3, h6: the reported device was returned to the designated complaint unit for independent evaluation.There was a relationship found between the device and 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.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.A review of the device drawings found a stress relief collar is now attached at the connection between the shaft and the hub of the suture capture loop.This design change was implemented as a result of a corrective action initiated to address the reported issue.A visual inspection of the returned device found that it is not in its original packaging.The shafts of the menders are separated from the knobs, which were not returned.The proximal end of one of the devices is twisted and deformed while the other is broken cleanly.There does not appear to be any debris on the devices.The complaint was confirmed, and the root cause was associated with device design.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.A corrective action for this failure mode is in place.H11: corrected data d7a.
|