It was reported that a patient underwent microscopic examination of the right knee, reconstruction of the medial patellofemoral ligament and release of the lateral retinaculum due to the dislocation of the right patella.After the procedure using twinfix anchor, it was found that the wound of the right knee exuded repeatedly, and the dressing was changed for many times but there was no effect.A debridement was performed due to exudation.The patient current status is fine.
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H10: internal complaint reference: (b)(4).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 way to determine if the device contributed to 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 review of risk management files found that there was insufficient information to tie the reported complaint to specific line items within the risk file.Based on the information provided, a debridement was performed due to exudation and the patient is currently doing fine.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant patient information be provided, this case would be re-assessed.The complaint was not confirmed.Factors that could have contributed to the reported event include an adverse biological response to the procedure, inadequate cleaning of the surgical site, or failure of a concomitant 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.
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