Arthrex® AR-1204AF-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867004207), received between Jan 31, 2022 and Jan 31, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Dull, Blunt” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2022Dull, Blunt; Output Problem

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA THE PHONE THAT AN AR-1204AF-60 FLIPCUTTER LOCKED AND WOULD NOT RETURN TO CLOSING POSITION. THIS WAS DISCOVERED DURING USE IN A KNEE PROCEDURE W/ MENISCAL ROOT REPAIR ON (B)(6) 2022. THE SURGEON USE THE FLIPCUTTER TO CREATE THE FEMORAL SOCKET. AFTER REAMING THE BLADE COLD-WELDED AND WOULD NOT CLOSE. THE SURGEON REMOVED THE AR-1204F-60 WITH THE BLADE IN THE OPEN POSITION, USING THE ENTIRE FEMORAL TUNNEL TO BE LARGER THAN EXPECTED. THE KNEE SCORPION SUTURE PASSER AR-12990, WAS USED TO PASS THE SUTURES FOR THE POSTERIOR REPAIR. THE SURGEON USED THREE DIFFERENT AR-12990 KNEE SCORPION WITH THREE AR-12990N'S 2 OF (LOT 1345569) BOTH NEEDLES DELAMINATING INSIDE THE AR-12990 WHILE THE SURGEON WAS TRYING TO PASS THROUGH (LOT 14109312) PUSHED LATERAL WHILE PASSING THROUGH JAMMING INSIDE THE TRAP DOOR. THE CASE WAS COMPLETED USING A 4TH AR-12990N WITH OUT ISSUE. THE SALES REPRESENTATIVE STATED 30-35 MINS WAS ADDED TO THE PROCEDURE, REQUIRING ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 13397818 ↗