It was reported that patient underwent a scapulate tendon repairment procedure on (b)(6) 2014.During the procedure, the plastic sheath stuck preventing the implant from advancing.Another juggerknot was utilized to complete the procedure.Additionally, re-drilling occured.
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under warnings, number 2 states, "improper selection, placement, positioning, and fixation of the device can lead to failure of the device or the procedure.".
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