Arthrex® AR-1204AF-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867004245), received between Nov 21, 2019 and Apr 28, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIP OF THE FLIP CUTTER BROKE. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. 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 21918621 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIP OF THE FLIP CUTTER BROKE. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. 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 21918469 ↗
• MalfunctionJun 18, 2024Use of Device Problem; Use of Device Problem

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1204AF-80, FLIPCUTTER® II, 8 MM, THE DRILL BIT DID NOT FLIP DURING SLOW BACKWARD PULLING OF THE DRILL IN THE ARTICULAR CAVITY TO PREPARE THE BONE CHANNEL SO THICKER BONE PASSAGES COULD NOT BE PREPARED. THIS WAS DETECTED DURING USE IN A TOTAL INTERNAL ANTERIOR FORK LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023 WHEN THE SURGEON HAD PREPARED THE LATERAL TIBIAL TUNNEL AND INSERTED THE AR-1204AF-80 FLIPCUTTER II DEEP INTO THE CUFF TO OPEN THE TUNNEL INTO THE JOINT CAVITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW AR-1204AF-80 WAS USED. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19557884 ↗
• MalfunctionMay 21, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE FLIPCUTTER DID NOT OPEN AND COULD NOT BE USED PROPERLY. 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 19360499 ↗
• MalfunctionApr 26, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE FLIP CUTTER DID NOT FLIP BACK AFTER REAMING THE TUNNEL. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 19192358 ↗
• MalfunctionApr 25, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE FLIPCUTTER DID NOT TRIGGER. 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 19185933 ↗
• MalfunctionSep 15, 2023Break; Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT SURGERY THE DEVICE BROKE DURING DRILLING. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT., ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 17758036 ↗
• MalfunctionJun 23, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-1204AF-80 FLIPCUTTER II BROKE DURING DRILLING. THE SURGEON SETS THE FLIPCUTTER II BLADE TO A 90-DEGREE ANGLE AND DRILLS IN THE FEMUR. THE BLADE BROKE, AND IT COULD NOT CLOSE TO ITS ORIGINAL POSITION. THIS WAS DISCOVERED DURING AN ACL PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING A NEW AR-1204AF-80 FLIPCUTTER II. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17191826 ↗
• MalfunctionFeb 20, 2023Break; Difficult to Remove

  ON 12/29/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1204AF-80 FLIPCUTTER II, 8 MM HAD AN ISSUE. WHEN ACTIVATING TO DRILL MODE AND DRILLING IN RETROGRADE MODE ON (B)(6) 2022, THE INTERNAL PART OF THE FLIPCUTTER CAME OUT COMPLETELY, IN ORDER TO EXTRACT IT THEY HAD TO USE A KELLY FORCEPS TO DEACTIVATE AND REMOVE IT. THE DEVICE WAS DISCARDED, BUT A PICTURE WAS PROVIDED. THIS WAS DISCOVERED DURING USE WITH NO CASE/PATIENT INVOLVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 2/1/2023, THE FOLLOWING INFORMATION WAS PROVIDED BY THE ARTHREX EMPLOYEE VIA EMAIL: THIS EVENT OCCURRED DURING A KNEE ARTHROSCOPY PROCEDURE. A PIECE OF THE INSTRUMENT BROKE INSIDE THE PATIENT AND ALL FRAGMENTS WERE RETRIEVED. THERE WAS NO INFORMATION AVAILABLE ON THE BONE QUALITY OF THE PATIENT, HOW THE CASE WAS COMPLETED, AND IF THE PATIENT WAS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16403481 ↗
• MalfunctionDec 27, 2021Positioning Problem

  ON (B)(6) 2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1204AF-80 FLIPCUTTER WAS STUCK AND COULD NOT BE RESTORED TO IT'S ORIGINAL POSITION CAUSING THE SURGEON TO DEVIATE FROM HIS INTENDED TECHNIQUE AND PREPARE A TUNNEL THROUGH THE SHIN. THIS WAS DISCOVERED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION OF THE RIGHT KNEE PROCEDURE ON (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 13087973 ↗
• InjuryNov 21, 2019Break; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ALL INSIDE ACL REPAIR SURGERY THE ARTHREX FLIPCUTTER AR-1204AF-80 WAS USED. THE FLIPCUTTER WORKED WELL DURING THE FEMORAL DRILLING. BUT THE DEVICE FAILED WHILE THE SURGEON WAS DRILLING THE TIBIAL TUNNEL. THE SURGEON HAD DRILLED FIVE TIMES, A 0.5CM SOCKET IN THE TIBIA, WHEN THE CUTTING BLADE SHATTERED. THE SURGEON RETRIEVED SOME OF THE BROKEN FRAGMENTS BUT IT WAS NOT POSSIBLE TO RETRIEVE THE LAST PIECE. IT WILL REMAIN INSIDE THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A NEW DEVICE OF THE SAME PART NUMBER. THERE WAS NO CHANGE OF THE SURGICAL TECHNIQUE AND ALSO NO SECOND SURGERY NECESSARY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9353310 ↗