Arthrex® AR-1204AS-75Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867004405), received between Nov 6, 2019 and Dec 29, 2025 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIP OF THE DEVICE DIDN'T OPEN FOR THE REAMING OF THE TIBIAL TUNNEL. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23916922 ↗
• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ALL-INSIDE ACL RECONSTRUCTION SURGERY THE DEVICE BROKE NEAR THE BLUE FLIPPING BUTTON WHILST DRILLING THE TIBIAL TUNNEL. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21311722 ↗
• InjuryNov 6, 2019Material Fragmentation

  IT WAS REPORTED THAT THE FLIPCUTTER II, AR-1204AS-75, WAS USED IN A PCL RECONSTRUCTION PROCEDURE, WHILE DRILLING THE TUNNEL, METAL POWDER WAS GENERATED FROM THE FLIPCUTTER AND REMAINED IN THE JOINT AS THE SURGEON WAS UNABLE TO RETRIEVE ALL THE METAL POWDER. THE SURGEON STOPPED USING THE FLIPCUTTER AND COMPLETED THE TUNNEL USING ANOTHER MANUFACTURER'S PRODUCT. ADDITIONAL INFORMATION RECEIVED 10/17/19: THE SURGEON DRILLED A FULL TUNNEL WITH THE SECOND FLIPCUTTER; HOWEVER, HE PLANNED ON DRILLING A FULL TUNNEL TO BEGIN WITH. THERE WERE NO PHOTOS TAKEN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9287414 ↗