Internal complaint reference (b)(4).H10 h3, h6: the reported device was received for evaluation.There was a relationship found between the returned 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.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.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 visual inspection found the device outside the original packaging.The insertion device has debris on it, the distal end is bent.The suture threads are still through the suture window in the anchor and the anchor is fractured at the proximal end.There is debris on the anchor and suture material.Based on the condition of the product material found during visual inspection, additional material testing is not required.This case reports the breakage of the footprint anchor and per case details the broken pieces were not retrieved from the patient.No clinically relevant supporting documentation was provided for inclusion in a medical investigation.The footprint anchor is implantable, biocompatibility is not an issue.Micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.It was also reported that an additional bone hole was required to complete the procedure and the impact to the patient is expected to be minimal.No further clinical/medical assessment is warranted at this time.The complaint was confirmed, and the root cause was associated with unintended use of the device.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.
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