Arthrex® AR-1204AS-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867004313), received between Feb 27, 2019 and Apr 23, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Break; Break

  ON 04/10/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-120AS-115 FLIPCUTTERS HINGE BROKE. THIS OCCURRED DURING AN ACL KNEE ARTHROSCOPY ON (B)(6) 2025 WHEN THE HINGE BROKE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE PATIENT HAD A VERY HARD BONE QUALITY. THIS CAUSED A 15-MINUTE DELAY THAT DID NOT REQUIRE ADDITIONAL ANESTHESIA. THEY USED ANOTHER TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892362 ↗
• InjuryFeb 27, 2019Deformation Due to Compressive Stress; Failure to Eject

  IT WAS REPORTED BY A SALES REP WHO WAS PRESENT THAT THE AR-1204AS-115, 11.5MM FLIPCUTTER, WAS USED IN A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2019. PER THE SALES REP, THE SURGEON PERFORMED THE FLIPCUTTER TECHNIQUE CORRECTLY. HE PRE-DRILLED IN THE FEMUR WITH A 3.5MM DRILL UNTIL THE INSIDE PORTION OF THE MEDIAL CONDYLE WAS REACHED. ONCE THE 3.5MM PREDRILL WAS COMPLETED, THE 11.5MM FLIPCUTTER WAS INTRODUCED THROUGH THE PREDRILLED HOLE INTO THE JOINT. PER THE SALES REP, THE SURGEON CORRECTLY DEPLOYED THE FLIPCUTTER COMPLETELY, AND THEN HE PERFORMED THE RETROGRADE DRILLING ACTION. THE SOCKET WAS CREATED WITHOUT ISSUE. HOWEVER, THE ISSUE CAME WHEN IT WAS TIME TO STRAIGHTEN OUT THE FLIP CUTTER AND PULL IT OUT OF THE 3.5MM STEP DRILL SLEEVE. THE FLIP CUTTER WAS STRAIGHTENED; HOWEVER, THE FLIPCUTTER COULD NOT BE REMOVED FROM THE JOINT. THE DOCTOR USED A PITUITARY AND PROBE TO DO HIS BEST TO STRAIGHTEN OUT THE FLIPCUTTER AS MUCH AS POSSIBLE, HOWEVER THE FLIPCUTTER WOULD NOT STRAIGHTEN OUT COMPLETELY, MAKING IT IMPOSSIBLE TO PULL IT OUT OF THE 3.5MM STEP DRILL SLEEVE. THE SURGEON ENDED UP HAVING TO PULL THE STEP DRILL SLEEVE OUT OF THE CORTEX OF THE LATERAL EPICONDYLE IN ORDER TO REMOVE THE FL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8375672 ↗