It was reported that, during a labrum repair surgery, the osteoraptor anchor broke while implantation.All the broken pieces were successfully retrieved with suture.The procedure was finished with a smith and nephew back up device, used in the originally drilled bone hole.No delay or further complications were reported.The health status of the patient is good.
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H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found similar reported events.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.Based on the information available, 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 of the returned device found that it is not in its original packaging.The implantation device and a fractured anchor, with the suture material through the suture window were returned.The distal end of the implantation device is deformed and the anchor is fractured just below the suture window.All of the returned items have debris on them.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 osteoraptor anchor and it is unknown if the broken pieces were retrieved from the patient.An undated photo of the inserter was provided for review, the anchor was not in the photo.Based on the information provided no clinical factors were found which would have contributed to the reported breakage.The osteoraptor anchor is implantable, biocompatibility is not an issue.If retained micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.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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