Arthrex® AR-1204AF-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00888867004269), received between May 3, 2018 and Jun 26, 2025 — classified as 3 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ALL-INSIDE ACL SURGERY THE TIP OF THE DEVICE BROKE AFTER THE TIP WAS FLIPPED. 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 22337060 ↗
• MalfunctionFeb 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC OSTEOTOMY THE TIP OF THE DEVICE BROKE OFF AFTER INSERTING INTO THE TISSUE. 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. UPDATE KPILZ 04-FEB-2025: ALL PARTS WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21320825 ↗
• MalfunctionFeb 4, 2025Break; Break

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT (3) AR-1204AF-90 FLIP CUTTERS BROKE. THIS OCCURRED DURING USE WHEN THE TIPS BROKE OFF WHILE MAKING THE TIBIAL TUNNEL AND THE RETRO DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307404 ↗
• MalfunctionFeb 4, 2025Break; Break

  ON 01/14/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT (3) AR-1204AF-90 BROKE. THIS OCCURRED DURING USE WHEN THE TIPS BROKE OFF WHILE MAKING THE TIBIAL TUNNEL AND THE RETRO DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307403 ↗
• MalfunctionFeb 4, 2025Break; Break

  ON 01/14/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT (3) AR-1204AF-90 FLIPCUTTERS BROKE. THIS OCCURRED DURING USE WHEN THE TIPS BROKE OFF WHILE MAKING THE TIBIAL TUNNEL AND THE RETRO DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307045 ↗
• MalfunctionNov 27, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY THE DEVICE BROKE WHILE DRILLING THE FEMORAL SOCKET. ALL FRAGMENTS WERE 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 20797473 ↗
• MalfunctionNov 8, 2024Break; Break

  ON 10/30/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT (3) AR-1204AF-90 FLIPCUTTERS BROKE. THIS OCCURRED DURING A LCA PROCEDURE ON (B)(6) 2024. THERE WAS NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641250 ↗
• MalfunctionNov 8, 2024Break; Break

  ON 10/30/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT (3) AR-1204AF-90 FLIPCUTTERS BROKE. THIS OCCURRED DURING A LCA PROCEDURE ON (B)(6) 2024. THERE WAS NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641190 ↗
• MalfunctionNov 8, 2024Break; Break

  ON 10/30/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT (3) AR-1204AF-90 FLIPCUTTERS BROKE. THIS OCCURRED DURING A LCA PROCEDURE ON (B)(6) 2024. THERE WAS NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641137 ↗
• MalfunctionJun 9, 2024Break; Break

  ON 3/6/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-1204AF-90 FLIPCUTTER II BROKE WHILE TRYING TO FLIP IT BACK AFTER REAMING THE FEMORAL TUNNEL. THE CASE WAS COMPLETED USING AN AR-1204AF-100. THIS WAS DISCOVERED DURING AN ALC PROCEDURE TO REPAIR THE COMPLETE ANTERIOR CRUCIATE LIGAMENT RUPTURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 3/7/2023: WHILE USING THE AR-1204AF-90 FLIPCUTTER II, THE BLADE WOULD NOT CLOSE TO ITS ORIGINAL STATE. IT DID NOT BREAK OFF OR HAVE ANY LOOSE FRAGMENTS INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19495245 ↗
• MalfunctionJun 6, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT KNEE SURGERY WHEN THE FLIPCUTTER WAS IN THE PATIENT THE WING LOCKED IN OPEN POSITION. NOTHING BROKE IN THE PATIENT. THE SURGEON DID NOT GO AS FAR AS HE WANTED IN DRILLING THE TIBIAL TUNNEL AND REMOVED THE FAILED FLIPCUTTER. ANOTHER FLIPCUTTER WAS NEEDED TO COMPLETE THE PROCEDURE. 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 19476572 ↗
• MalfunctionMay 16, 2024Use of Device Problem; Use of Device Problem

  ON 11/03/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-1204AF-90 FLIPCUTTER WOULD NOT FLIP ONCE THE FEMORAL TUNNEL WAS DRILLED. THE SURGEON WAS ABLE TO PRY THE FLIPCUTTER BLADE BACK USING A GRASPER. THIS WAS DISCOVERED DURING USE IN A ACL RECONSTRUCTION (B)(6) 2021. THE CASE WAS COMPLETED BY USING A NEW AR-1204AF-90.

  Patient problems: Insufficient Information

  MAUDE report 19332075 ↗
• MalfunctionApr 10, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING DT4 SURGERY BOTH BLADES DID NOT OVERBALANCED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED. UPDATE, 14-JAN-2021 -SAC. FAILURE IS CAN INSERT FIRST BLADE AND AFTER SECOND ONE INTO THE TUNNEL BECAUSE BLADE DIDN¿T WORKED.

  Patient problems: Insufficient Information

  MAUDE report 19079053 ↗
• MalfunctionJan 10, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE FLIPCUTTER COULD NOT BE FLIPPED. 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 18486981 ↗
• MalfunctionJan 10, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE FLIPCUTTER COULD NOT BE FLIPPED. 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 18486970 ↗
• MalfunctionJan 9, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY, WHEN DRILLING THE TIBIA, THE FLIPCUTTER PERFORMED WELL DRILLING FORWARD. IT FLIPPED TO 90 DEGREES INSIDE THE JOINT. HOWEVER, WHEN DRILLING BACKWARDS THE DOCTOR SAID IT DIDN'T FEEL RIGHT. WHEN HE ADVANCED FORWARD INTO THE JOINT THE FLIP WAS NO LONGER AT 90 DEGREES. HE DID THIS TWO MORE TIMES WITH SAME RESULT. THE FLIPCUTTER WAS PLACED INSIDE THE DRILL WITH ENOUGH ROOM ON THE STEM SO IT WOULD FLIP PROPERLY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT 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 18474094 ↗
• MalfunctionJan 8, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE FLIPCUTTER COULD NOT BE FLIPPED. 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 18467696 ↗
• MalfunctionOct 24, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE PIN FOR TILTING BROKE ON THE BONE DURING THE FIRST CONTACT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW FLIPCUTTER MODELL 3. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 26-SEP-2023 NROE: IT WAS CONFIRMED THAT ALL BROKEN PIECES COULD BE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995753 ↗
• MalfunctionOct 12, 2023Defective Device; Defective Device

  ON (B)(6) 2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-06032170 THAT AN AR-1204AF-90 FLIPCUTTER® II WAS NOT DRILLING. THIS OCCURRED DURING AN LCA PROCEDURE, WHEN GOING TO DRILL THE DEVICE WOULD NOT PERFORM. THE DEVICE APPEARED TO NOT BE FIXED AND NEEDED TO BE REPLACED WITH A DEVICE THAT CREATED A LARGER DIAMETER. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17919577 ↗
• MalfunctionMay 15, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE MOUTHPIECE BROKE OFF. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. 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 16929453 ↗
• MalfunctionMay 11, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE TIP OF THE DEVICE BROKE OFF. THE BROKEN PIECES WERE RETRIEVED 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 16914583 ↗
• MalfunctionApr 28, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE BROKE INSIDE THE PATIENT. ALL FRAGMENTS 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. UPDATE AVOE (B)(6) 2023. IT WAS CONFIRMED THAT NO SECOND SURGERY WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16839675 ↗
• MalfunctionApr 17, 2023Break; Break

  IT WAS REPORTED THAT DURING A GRAFTLINK SURGERY THE DEPLOYABLE PART OF THE DEVICE BROKE WHILE DRILLING. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW FLIPCUTTER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751170 ↗
• MalfunctionNov 9, 2022Break

  IT WAS REPORTED THAT DURING A KNEE LIGAMENTOPLASTY SURGERY THE FLIP CUTTER BROKE IN THE PATIENT'S KNEE. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. 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 15758641 ↗
• MalfunctionOct 31, 2022Break

  ON 10/10/2022, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT A AR-1204AF-90 FLIPCUTTER BROKE. THIS OCCURRED ON (B)(6) 2022 DURING AN UNKNOWN PROCEDURE WHEN MAKING THE FEMORAL TUNNEL, THE FLIPCUTTER BROKE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 10/13/2022, IT WAS REPORTED THAT THIS INCIDENT OCCURRED DURING A KNEE ARTHROSCOPY/ACL RECONSTRUCTION, AND THE BROKEN FRAGMENTS WERE FULLY RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15698153 ↗