Arthrex® AR-1204AS-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867004306), received between Jul 25, 2022 and Mar 27, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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.

• MalfunctionMar 27, 2023Break; Break

  IT WAS REPORTED THAT WHILE RETROGRADE DRILLING DURING AN ALL-INSIDE ANTERIOR CRUCIATE LIGAMENT SURGERY THE SHAFT BROKE AND THE CUTTER CAME LOOSE. THE BROKEN-OFF PIECE COULD BE REMOVED BY DOING A COMPLETE TIBIAL SOCKET, AS RESULT, IT WAS NECESSARY TO IMPLANT A LARGER BUTTON. THERE WAS NO HARM TO THE PATIENT, OPERATOR, OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH AN 11MM DRILL. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618226 ↗
• MalfunctionAug 15, 2022Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIP OF THE DEVICE BROKE OFF. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PARTS OUT OF THE PATIENT. ACCORDING TO THE SURGEON THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 15223778 ↗
• MalfunctionJul 25, 2022Break

  ON 7/6/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1204AS-110 FLIPCUTTER II BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 15093135 ↗