It was reported that during shoulder rotator cuff repair, the footprint ultra pk suture anchor was fractured when was being screwed-in.The pieces were removed by tweezers from the patient.A backup device was available to complete the procedure with no significant delay or other complications.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Part of the reported device was received for evaluation.There was no way to determine if the device contributed to the reported event.A complaint history review concluded this was a repeat issue.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 review of risk management files found that the reported failure was documented appropriately.¿ a review of the polymer found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.A review of the customer provided image found that it is on a carton with labelling, but the image quality is too poor to determine the product identification information.There is no anchor pictured, and the distal end of the inserter is bent.A visual inspection of the returned device found that it is not in its original packaging.The device has been deployed, but the anchor and sutured were not returned with the device.The distal end of the inserter is bent, and there is debris on the device.Based on the condition of the product material found during visual inspection, additional material testing is not required.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.The complaint was not confirmed, and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.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.
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