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

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00888867004436), received between May 12, 2017 and Jan 23, 2026 — classified as 9 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (30 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Break

  ON 08TH JAN 2026, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AR-1204AS-90 SERIAL (B)(6) FLIPCUTTER II BLADE SNAPPED OFF AFTER THE DRILLING OF BONE TUNNEL DURING KNEE ACL ALL-INSIDE RECONSTRUCTION ON (B)(6) 2026: LEAVING THE BLADE INSIDE PATIENT¿S JOINT. DESPITE THAT, THE OPERATION IS COMPLETED WITH A NEW FLIPCUTTER AND BROKEN PIECE WAS RETRIEVED FROM THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24160760 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ALL INSIDE ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIP OF THE DEVICE BROKE. ALL PARTS 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 23380187 ↗
• MalfunctionDec 6, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ALL-INSIDE ANTERIOR CRUCIATE LIGAMENT SURGERY THE FLIPCUTTER NO LONGER FLIPPED BACK DURING RETROGRADE DRILLING. 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 20866137 ↗
• MalfunctionOct 16, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY THE FLIP CUTTER DID NOT LOCK IN THE TIBIA WHEN THE SURGEON TRIED TO OPEN THE FLIPCUTTER TO THE FULL DIAMETER. 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 20461296 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY THE TIP OF THE DEVICE BROKE OFF. 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 20267994 ↗
• MalfunctionSep 12, 2024Break; Break

  ON (B)(6) 2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-1204AS-90 FLIPCUTTER II BROKE PARTWAY THROUGH THE FEMORAL TUNNEL. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20205723 ↗
• MalfunctionJun 19, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED DURING AN ACL PROCEDURE, THE FLIP CUTTER WOULD NOT LOCK IN THE STRAIGHT POSITION WHEN PRESSING THE BUTTON. A SECOND AR-1204AS-95 WAS BROUGHT IN AND USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19568097 ↗
• MalfunctionJun 14, 2024Break; Break

  ON 11/11/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT WHILE THE SURGEON WAS USING AN AR-1204AS-90 FLIPCUTTER II, AND WHEN TRYING TO STRAIGHTEN THE DEVICE TO REMOVE FROM THE KNEE OF THE PATIENT, THE BUTTON MECHANISM BROKE. WITH SOME MANEUVERING THE SURGEON WAS ABLE TO REMOVE THE DEVICE WITH NO HARM TO THE PATIENT. THIS WAS DISCOVERED DURING USE IN AN ALLO GRAFT ALL INSIDE QUADLINK ACL ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING A NEW AR-1204AS-90.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537832 ↗
• MalfunctionMay 2, 2024Break; Break

  ON 04/09/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1204AS-90 FLIPCUTTER BROKE DUE TO THE HARD BONE DURING ACL RECONSTRUCTION SURGERY. THE BROKEN BLADE TIP WAS RETRIEVED IMMEDIATELY. THIS WAS DISCOVERED USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19233764 ↗
• MalfunctionApr 30, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 10/11/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1204AS-90 FLIP CUTTER BLADE WOULD NOT FLIP BACK. THIS OCCURRED DURING AN ACL RECONSTRUCTION WHEN THE FLIP CUTTER BLADE WOULD NOT FLIP BACK AFTER RETRO-DRILLING THE FEMORAL TUNNEL. THERE DID NOT APPEAR TO BE ANY BONE STILL STUCK IN THE DEVICE, AND THE SURGEON SPENT QUITE A BIT OF TIME TRYING TO GET THE BLADE TO FLIP BACK. HE WAS ABLE TO BEND IT BACK WITH A NEEDLE DRIVER, BUT NOT WITHOUT COMPROMISING THE DEVICE. THERE WAS NO PATIENT EFFECT REPORTED, NO FRAGMENTS WERE LEFT IN THE PATIENT. ADDITIONAL INFORMATION PROVIDED 10/11/2021 THE BONE QUALITY WAS GOOD NOTHING OUT OF THE ORDINARY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211828 ↗
• MalfunctionMar 4, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ALL INSIDE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE TIP OF THE DEVICE BROKE OFF WHILST REAMING THE FEMORAL TUNNEL. THIS HAPPENED 3 TIMES IN A ROW WITH DIFFERENT FLIPCUTTERS FROM THE SAME LOT NUMBER. THE 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 OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18833547 ↗
• MalfunctionMar 4, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ALL INSIDE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE TIP OF THE DEVICE BROKE OFF WHILST REAMING THE FEMORAL TUNNEL. THIS HAPPENED 3 TIMES IN A ROW WITH DIFFERENT FLIPCUTTERS FROM THE SAME LOT NUMBER. THE 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 OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18833538 ↗
• MalfunctionMar 4, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ALL INSIDE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE TIP OF THE DEVICE BROKE OFF WHILST REAMING THE FEMORAL TUNNEL. THIS HAPPENED 3 TIMES IN A ROW WITH DIFFERENT FLIPCUTTERS FROM THE SAME LOT NUMBER. THE 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 OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18833527 ↗
• MalfunctionFeb 1, 2024Use of Device Problem; Physical Resistance/Sticking; Use of Device Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT ALL INSIDE RECONSTRUCTION THE FLIP CUTTER FAILED TO FLIP BACK FROM 9MM TO 3.5MM. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. THE FEMORAL TUNNEL WAS REAMED THROUGH THE FIRST CORTEX AND AN EXTENDER BUTTON WAS USED TO FINISH THE SURGERY SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18621673 ↗
• MalfunctionJan 25, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT ALL-INSIDE SURGERY THE OUTER SHELL OF FLIPCUTTER BROKE. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE. A SECOND SURGERY WAS REQUIRED. UPDATE AVOE 04-JAN-2024 IT WAS CONFIRMED THAT NO SECOND SURGERY WAS REQUIRED AND THE DEVICE BROKE DURING SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 18582256 ↗
• MalfunctionJun 1, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE CUTTING TIP BROKE OFF FROM THE SHAFT OF THE DEVICE. THE SURGEON HAD TO USE A DIFFERENT DEVICE FROM ANOTHER MANUFACTURER TO RETRIEVE THE BROKEN PIECES. 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 17037313 ↗
• MalfunctionMay 15, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE FRONT PART OF THE DEVICE BROKE INSIDE THE PATIENT. THE SURGEON HAD TO USE THE JACOBS TO RETRIEVE THE BROKEN OFF PARTS OF THE DEVICE FROM THE PATIENT. NO BROKEN PARTS REMAINED INSIDE THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 16930238 ↗
• MalfunctionMay 1, 2023Break; Break

  ON 4/5/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1204AS-90 FLIPCUTTER II INNER SHEATH WAS DISASSOCIATED FROM THE OUTER SHEATH. THE SURGEON WAS ABLE TO ADVANCE THE OUTER SHEATH BACK INTO THE JOINT AND GET IT CLOSED TO REMOVE IT FROM THE TUNNEL ENSURING NO FRAGMENTS WERE LEFT BEHIND IN THE PATIENT'S KNEE. CASE WAS COMPLETED USING ANOTHER AR-1204AS-90 FLIPCUTTER II. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16846968 ↗
• InjuryApr 11, 2023Defective Device; Defective Device

  ON (B)(6) 2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-1204AS-90 FLIPCUTTER II WOULD NOT FLIP BACK AFTER DRILLING THE FEMORAL AND TIBIAL TUNNEL. SURGEON WANTED TO PERFORM AN ALL-INSIDE ACL PROCEDURE; HOWEVER, DUE TO THE FAILED MECHANISM OF THE FLIPCUTTER II, THE SURGEON HAD TO DRILL A FULL TUNNEL INSTEAD, UNABLE TO PERFORM AN ALL-INSIDE. THIS PROCEDURE TOOK PLACE ON (B)(6) 2023.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16713776 ↗
• MalfunctionMar 16, 2023Break; Break

  IT WAS REPORTED THAT DURING KNEE SURGERY, THE FLIP-CUTTER PIN BROKE INSIDE THE PATIENT IN THE OPEN POSITION AND WAS THEREFORE VERY DIFFICULT TO REMOVE. BUT THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THERE WAS NO HARM TO THE 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552657 ↗
• MalfunctionJan 3, 2023Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGERY DURING FEMORAL DRILLING THE TIP OF THE FLIPCUTTER BROKE OFF. THE BROKEN PIECE WAS 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 16087102 ↗
• MalfunctionOct 24, 2022Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT SURGERY THE TIPS OF THE DEVICES BROKE. 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 15657420 ↗
• MalfunctionJun 6, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-1204AS-90 FLIPCUTTER II BROKE IN THE KNEE. THIS WAS DISCOVERED DURING A PROCEDURE AND BROKE INSIDE THE JOINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14603918 ↗
• MalfunctionDec 7, 2021Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE SEAM WELD OF THE FLIPCUTTER BROKE CLOSE TO THE BLUE HOUSING FOR THE FLIPPING MECHANISM. THE BROKEN OFF PIECE WAS 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 12953306 ↗
• MalfunctionNov 30, 2021Break

  IT WAS REPORTED THAT DURING A SURGERY THE MATERIAL BROKE INSIDE THE JOINT OF THE KNEE AND DEBRIS WAS PRODUCED. THE SURGEON HAS CLEANED THE JOINT AND REMOVED THE DEBRIS. THE SURGEON REPORTED THAT 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. 09-NOV-2021 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT THE REPORTED EVENT OCCURRED DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY AND THAT THE TIP OF THE CUTTER BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12895873 ↗