Product complaint # = > (b)(4).Udi: ((b)(4).Visual examination of the single-inner setscrew revealed signs of operative use as evidence by superficial markings, with threads and drive feature slightly worn.It was noted that the rod striations were observed on the set screw suggesting that the set screw were seated properly.A functional analysis was performed with a poly-axial screw and x25 inserter from which it was noted the set screw could easily threaded into the screw head.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A functional analysis was performed with a poly-axial screw and x25 inserter from which it was noted the set screw could easily threaded into the screw head as well as, rod striations were observed on the set screw suggesting that the set screw were seated properly.The investigation could not verify or identify any evidence of the instrument contribution to the reported problem.It is not suspected that the instrument failed to meet specifications.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|