It was reported that 3 years after a surgery in the left index finger were a minitac was used, the patient presented redness and pain.Antibiotics and anti-inflammatories were prescribed.The event was not resolved and the patient had increased pain.The event was treated with surgery to remove the screw, as well as the bone marrow around since it was found to be infected and necrotic.The patient is in good condition now.
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H10: h3, 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 relationship found between the device and the reported event.A complaint history review found no 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No wound cultures were provided.Two undated/unlabeled left hand x-rays images and two fluoroscopic views of the left hand were provided and confirm the placement of the minitac anchor.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.The patient impact beyond the reported, symptoms, necrosis and additional surgery with screw removal cannot be determined.Therefore, no further clinical/medical assessment is warranted.The complaint was not confirmed.Factors that could have contributed to the reported event include insufficient or improper cleaning of the surgical site, or a biological response unrelated to the device.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.H11: h2: correction on h6 (health effect - clinical code).
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