The device was received for investigation with the screw intact.There appeared to be damage on the screw, however, it is unknown if the damage occurred when the screw was placed back in the device or if it had been taken apart at the facility.This customer also returned another rongeur for an issue of sticking, this device also showed damage on the screw.Based on this information, it can be determined that the end user is removing the screws for cleaning.The screws of these devices are not intended to be removed, they are ping welded by the supplier to help prevent them from backing out during use.Once this weld is broken by removal at the user facility, it can back out during use.There have been 4 total complaints recorded for screws coming out of 58-3200j-bd and 58-3200-bd since 2012.In all cases the screws showed damage indicative of being removed at the user facility.There has been a total of (b)(4) sold 58-3200j-bd.There has been a total of (b)(4) sold of 58-3200-bd.This can be seen as the final report, if additional information is obtained that alleges additional patient involvement or the need for corrective actions, a follow up report will be submitted.
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