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Model Number LO-PRO SCRW,TI,4.5X 45MMCANN |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 06/06/2019 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The broken screw head that was removed was lost after being washed and will not be returning.The root cause of the event could not be determined from the information available and without device evaluation.
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Event Description
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It was reported during a tibial tubercle osteotomy procedure, as the surgeon was tightening the ar-8945-45ft low profile screw the head of the screw popped off.The rep stated the threads of the screw were holding fine, just the 2mm head popped off.The screw stayed implanted and the broken head of the screw was retrieved as it was not inserted into the bone.The implant was seated at a depth of 45mm.The bone quality was hard.The case was completed and an unplanned incision was not made.Additional information received on 06/12/2019: the bone was prepped with a 3.0 drill bit.The full length of the screw threads remains implanted in the tibia.The screw held and the surgeon was happy with the fixation so there were not any attempts made to remove the threaded portion of the screw.A second screw was not needed, and a graft was not used.The broken screw head that was removed was lost after being washed and will not be returning.
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Search Alerts/Recalls
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