Device used for treatment and not diagnosis.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The investigation could not be completed, no conclusion could be drawn, as no product was received.A review of the device history records has been requested.
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Additional narrative: a pd event evaluation was conducted.The report indicates that a small titanium rib hook (part 04.641.002, lot 7495437) was returned attached to a titanium proximal extension size 5 (part 04.641.055, lot 6440301), with the complaint that the hook would not remove and the surgeon assessed the set screw was broken somehow.The returned parts were examined and it was seen that the nut on the rib hook has external gouge markings along the entire circumference of the nut which indicate that it has seen excessive force and may be stripped.The diameter of rod portion of part 04.641.055 (lot 6440301) was measured and found to be within tolerance, therefore improper dimension of the proximal extension can be ruled out as a cause for this complaint.The drawings for this part were examined and there were no design changes required, and no changes have been made to the design since this part was released to the warehouse in october of 2013.The material is also found to be suitable for its intended use.This complaint for the rib hook is confirmed, however the proximal extension does not appear to be a factor for the complaint.The design and materials were found to be adequate for the intended use and did not contribute to the complaint condition.If the proper rib hook holder, veptr nut driver shaft and 5nm torque limiting handle were used in this procedure, then the nut should not have ended up over tightened and stripped to the point that the proximal extension could not be removed.The proxima extension (part # 04.641.055) is within specification and did not contribute to the reported failure.The returned device is considered a concomitant device.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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