SCORPION NEEDLE, KNEE

Description of Event or Problem

ON 13-FEB-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A QTY. 7 OF AR-7250 FIBERWIRE #0, A QTY. 5 OF AR-7200 FIBERWIRE #2, A QTY. 1 OF AR-7535 FIBERLINK SUTURE TAPE WERE BEING CUT BY AN AR-12990N SCORPION NEEDLE DURING A MENISCAL ROOT REPAIR PROCEDURE. ANOTHER AR-12990N NEEDLE WAS OPENED BUT CONTINUED TO CUT THE SUTURES. AN AR-4068-90 SUTURE LASSO WAS THEN USED AS AN ALTERNATIVE TO TRY AND PASS THE SUTURES THROUGH TISSUE, BUT WAS ALSO UNSUCCESSFUL. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SHOULDER SCORPION. NO PATIENT HARM WAS REPORTED, AND NO PIECES BROKE OFF INSIDE THE PATIENT.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.