Arthrex® AR-1204AF-95Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888867004276), received between Jun 6, 2019 and Oct 16, 2025 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR THE DEVICE MALFUNCTIONED AND JAMMED IN THE KNEE DURING USE. IT WAS FURTHER REPORTED THAT THE FLIPCUTTER BROKE AND THE OUTER TUBE CAME AWAY FROM THE INNER TUBE LEAVING THE INNER TUBE IN THE BONE. IT WAS FURTHER REPORTED THAT THE DEVICE BECAME TWISTED IN THE PROCESS. THE BROKEN PIECE WAS SAFELY REMOVED OUT OF THE PATIENT AND NO HARM WAS CAUSED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH A DIFFERENT 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 23309847 ↗
• MalfunctionJun 5, 2025Break; Break

  ON 17TH MAY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1204AF-95, FLIPCUTTER® II, 9.5 MM, BROKE THE MOMENT THE SURGERY TEAM START REAMING. THE FLIPCUTTER WAS ALREADY SPINNED FIRST BEFORE TOUCHING THE BONE, HOWEVER, UPON TOUCHING THE BONE, IT SNAPPED. THIS WAS DETECTED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY OPENING ANOTHER 9.5 FLIPCUTTER. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22149802 ↗
• MalfunctionMay 12, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1204AF-95, FLIPCUTTER® II, 9.5 MM BENT AFTER IT FLIPPED. THIS WAS DETECTED DURING USE IN AN ACL RECONSTRUCTION SINGLE BUNDLE PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NEW FLIPCUTTER FROM THE SET ITSELF.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005384 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE TIP OF THE FLIPCUTTER DID BREAK OFF WHEN TOUCHING THE BONE. THE DRILLING WITH THE FLIPCUTTER STARTED WITHOUT TOUCHING THE BONE. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM 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 21079211 ↗
• MalfunctionSep 6, 2024Failure to Advance; Failure to Advance

  ON 08/14/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-2324KBCSP SWIVELOCK SHUTTLING SUTURE BROKE AND AN AR-1204AF-95 FLIPCUTTER® II BUTTON WOULD NOT DEPLOY. BOTH COMPLAINT DEVICES WERE REPLACED WITH ANOTHER DEVICE WITHOUT ANY ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 8/19/2024: THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE. THERE WAS NO CASE DELAY REPORTED. THE BROKEN SUTURE OF THE AR-2324KBCSP SWIVELOCK WAS REMOVED FROM THE PATIENT. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158966 ↗
• MalfunctionOct 17, 2022Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT ALL INSIDE SURGERY A PART OF THE DEVICE BROKE OFF WITHOUT IMPROPER HANDLING DURING TIBIAL DRILLING IN THE PATIENT'S KNEE. 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 THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615590 ↗
• MalfunctionMay 25, 2022Break; Entrapment of Device

  ON (B)(6) 2022, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-1204AF-95 FLIPCUTTER II BROKE DURING REAMING THE FEMORAL BONE SOCKET. SURGEON DID NOT RETRIEVE THE BROKE PIECE AND IT REMAINS IN THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14496580 ↗
• MalfunctionMay 23, 2022Break

  IT WAS REPORTED THAT DURING A LIGAMENTOPLASTY KNEE ARTHROSCOPY ON THE (B)(6) 2022 THE DEVICE BROKE. ALL FRAGMENTS WERE REMOVED 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 14469451 ↗
• MalfunctionMay 16, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-1204AF-95 FLIPCUTTER BLADE BROKE. THIS OCCURRED DURING A CASE AND BROKE INSIDE THE PATIENT.PER FACILITY: "DRILLING BEGINS WITH A 3.5 MM DRILL BIT AND WHEN IT IS INSIDE THE JOINT AND THE INPUT IS FLIPPED, THE TIP BREAKS, LEAVING THE 9.5 MM BROCADE, LEAVING THE TIP OF THE INPUT INSIDE THE PATIENT. WHICH HAPPENS SAME PROCESS A SECOND TIME."

  Patient problems: Foreign Body In Patient

  MAUDE report 14407154 ↗
• MalfunctionMay 16, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-1204AF-95 FLIPCUTTER BLADE BROKE. THIS OCCURRED DURING A CASE AND BROKE INSIDE THE PATIENT.PER FACILITY: "A TUNNEL IS MADE WITH A 35 MM BROCADE, AT THE MOMENT OF FLIPPING, THE TIP BREAKS, A 9.5 BIT REMAINS, LEAVING PARTS INSIDE THE PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 14407094 ↗
• InjuryJan 31, 2022Mechanical Problem; Difficult to Open or Close

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1204AF-95 FLIPCUTTER AFTER DRILLING ONE TUNNEL WE HAD ISSUES WITH THE DRILL FLIPPING, THE BLADE WAS STUCK IN THE OPEN POSITION. THE SURGEON USED A NUMBER OF TOOLS TO CLOSE THE CUTTING BLADE AND REMOVE THE DEVICE FROM THE PATIENT. THIS WAS DISCOVERED DURING USE IN A PROCEDURE ON (B)(6) 2022. THE CASE WAS COMPLETED BY USING A NEW FLIPCUTTER TO DRILL THE SECOND TUNNEL. ADDITIONAL INFORMATION 1/18/2022: ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1204AF-95 FLIPCUTTER AFTER DRILLING THE BLADE WAS STUCK IN THE OPEN POSITION. THE SURGEON USED A NUMBER OF TOOLS TO CLOSE AND REMOVE THE AR-1204AF-95. THE SURGEON DRILLED FEMORAL TUNNEL AND AFTER REMOVING THE FLIPCUTTER HAD ISSUES OPENING AND CLOSING THE DEVICE. THE SURGEON USED A DIFFERENT FLIPCUTTER TO AVOID ANY FURTHER ISSUES AND THE CASE WAS COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 13397937 ↗
• MalfunctionNov 2, 2021Material Separation

  IT WAS REPORTED THAT DURING A ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE BROKE. 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. ON 13-OCT-2021 UPDATE DW: FURTHER INFORMATION WERE PROVIDED THAT THE FLIP CUTTER BROKE OFF INSIDE THE PATIENT AFTER DRILLING. THE SURGEON WAS ABLE TO RETRIEVE THE BROKE PART OUT OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12738436 ↗
• MalfunctionMay 24, 2021Break

  IT WAS REPORTED DURING A L. ACL REPAIR PROCEDURE THE TIP OF THE AR-1204AF-95 BROKE OFF. THE BROKEN FRAGMENT WAS RETRIEVED, AND THE CASE WAS COMPLETED BY USING ANOTHER AR-1204AF-95.

  Patient problems: Insufficient Information

  MAUDE report 11872441 ↗
• MalfunctionApr 26, 2021Break

  IT WAS REPORTED THAT DURING A ARTHROSCOPIC KNEE SURGERY THE DEVICE BROKE OFF INSIDE THE PATIENT. THE SURGEON RETRIEVED ALL PARTS OUT OF THE PATIENT. 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 11725298 ↗
• MalfunctionMar 2, 2021Break

  IT WAS REPORTED THAT DURING FEMORAL DRILLING, THE BLADE OF THE DEVICE BROKE OFF IN THE JOINT. EVERYTHING COULD BE REMOVED COMPLETELY. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE ANTERIOR CRUCIATE LIGAMENT KNEE 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 11398337 ↗
• MalfunctionFeb 1, 2021Break

  IT WAS REPORTED THAT DURING AN ALL INSIDE SURGERY WHILE DRILLING THE TUNNEL, THE BLADE BROKE OFF. THE SURGEON WAS ABLE TO RETRIEVE THE DEVICE OUT OF THE PATIENT. 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: Failure of Implant

  MAUDE report 11258759 ↗
• InjuryJul 23, 2019Break; Entrapment of Device

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, THE SURGEON WAS DRILLING WITH A 9.5MM FLIPCUTTER, AR-1204AF-95, AND THE BLADE SNAPPED OFF. THE BLADE COULD NOT BE LOCATED. THE SURGEON THEN OPENED A 10MM FLIPCUTTER, AR-1204AF-100, AND THE TIP OF THIS FLIPCUTTER ALSO BROKE WHILE THE SURGEON WAS DRILLING. THE BROKEN BLADE WAS CLEARLY VISIBLE AND EASILY REMOVED FROM THE JOINT USING A GRASPER. THE PATIENT HAD AN X-RAY POST-CASE WHICH CONFIRMED THAT THE BROKEN BLADE OF THE 9.5MM FLIPCUTTER WAS STILL IN THE KNEE JOINT. PATIENT HAD TO GO UNDER GA AGAIN SO THAT THE SURGEON COULD RETRIEVE THE BLADE. ADDITIONAL INFORMATION PROVIDED 7/3/19: THE SURGEON ENDED UP DRILLING A FULL TIBIAL TUNNEL WITH THE REUSABLE 10MM REAMER (AR-1214) , RATHER THAN A 35MM SOCKET HE WOULD HAVE CREATED WITH THE FLIPCUTTER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8817409 ↗
• InjuryJun 6, 2019Break; Entrapment of Device; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A FEMALE PATIENT HAD SURGERY ON HER LEFT KNEE. THE PATIENT SUFFERED CRUCIATE LIGAMENT RUPTURE - ANTERIOR CRUCIATE LIGAMENT AND ALSO HAD CRACKINGS OF THE INNER MENISCUS HORN DUE TO A SPORTIVE ACCIDENT. THE SURGERY TOOK PLACE ON THE (B)(6) 2016. DURING THAT SURGERY THE TIP OF ARTHEX DEVICE - AR-1204AF-95 BROKE OFF INSIDE THE PATIENT WHICH WAS NOT NOTICED BY THE SURGEON. THE SURGEON GOT AWARE OF THIS POST-OP WHEN A X-RAY AND A COMPUTER TOMOGRAPHY OF THE KNEE WAS PERFORMED. ALSO IT WAS NOTICED THAT THE FEMORAL DRILL CHANNEL WAS NOT DEEP ENOUGH. THATS WHY THE SURGEON DECIDED TO PERFORM A REVISION SURGERY. THE REVISION SURGERY TOOK PLACE ON THE (B)(6) 2016 IN THE SAME HOSPITAL WITH THE SAME MEDICAL STAFF. THE ARTHREX DEVICE AR-1204AF-100 WAS USED THIS TIME. DURING THE PROCEDURE THE TIP OF THE DEVICE BROKE AGAIN. (B)(4). AT THE MOMENT ARTHREX IS NOT INFORMED IF THE BROKEN TIP FRAGMENT WAS RETRIEVED IMMEDIATELY. POST OP OF THE REVISION SURGERY THE PATIENT WENT TO SEE ANOTHER DOCTOR IN ANOTHER HOSPITAL TO GET A NEUTRAL OPINION. THIS DOCTOR THEN DETERMINED THAT A PARTIAL RUPTURE OF THE CRUCIATE LIGAMENT PLASTY AND ALSO IN ADDITION A MENISCUS DAMAGE HAD OCCURRED DUE TO TH

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant

  MAUDE report 8674164 ↗