The navio soft tissue protector, (pn 101092), used in treatment was returned for a prior investigation and discarded.A relationship between the reported event and the device was established.Photos of the device from the prior investigation showed that the bone pin was stuck in the tissue protector.Dhr review found that no conditions that could contribute to the reported event were found.The reported product met manufacturing specifications prior to being released for distribution.A complaint history review found similar reports, this issue will continue to be monitored.The surgical technique guide released at the time of the complaint provides instructions for using the tissue protector.Specifically, the guide does provide instruction on how to prepare the bone pin insertion location on the patient and how to insert the tissue protector within that location.The functional evaluation suggests that the cause of the complaint concerns the design of the tissue protector.Specifically, as part of the functional evaluation that replicated the issue, the test operator followed the instructions provided in the surgical technique guide and experienced the bone pin getting stuck in the tissue protector.Accordingly, product labeling has been ruled out as a cause of the complaint.This failure is an identified failure mode within the risk file.Based on prior complaints received, it is likely that the event occurred due to the reported failure.The malfunction is due to a design issue due to the inner diameter of the tissue protector lumen diameter relative to the major diameter of the bone pin.Binding of the bone screw to the tissue protector is primarily due to tissue being wrapped around the threads.However, initial pin misalignment and bending of the pin are also contributing factors.Hhe-2020-12-pl and capa 200017 were opened as corrective actions to address this issue.As a result of the remedial investigation, we have thoroughly investigated the complaint per the criteria as required by 21 cfr 820.198(d).
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