Arthrex® AR-1204AS-85Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00888867004429), received between Jul 16, 2018 and Aug 26, 2026 — classified as 4 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50450340 ↗
• MalfunctionAug 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50438259 ↗
• MalfunctionAug 25, 2026Break

  It was reported that during the reconstruction of the anterior cruciate ligament, the tip of two AR-1204AS-85 broke off. The broken pieces were retrieved from the patient. In addition, the blade of a third AR-1204AS-85 could no longer be retracted after 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 50438018 ↗
• MalfunctionAug 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIP OF THE FLIP CUTTER BROKE OFF DURING DRILLING. ALL BROKEN 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 22814794 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGERY WHILE DRILLING THE DEVICE BROKE IN THE PATIENT. SURGEON MANAGED TO REMOVE THE RETAINED PIECE OF METAL AFTER A BIT OF A STRUGGLE AND THEN CHECKED IT AGAINST THE FLIPCUTTER TO SEE IF COMPLETE. HOWEVER, THE SURGEON WAS STILL UNSURE IF THERE WAS NOTHING RETAINED IN THE PATIENT. A WASHOUT OF THE WHOLE KNEE WAS DONE ATHROSCOPICALLY. A SERIES OF X-RAYS WAS DONE TO SEE IF IT WILL SHOW ANY METAL BITS RETAINED IN THE KNEE SO AS TO RETRIEVE THEM IF ANY. SURGEON AND ASSISTANT WENT THROUGH ALL THE SUCTION BOTTLES TO SEE THE PIECE OF METAL CAME OUT DURING THE WASH BUT COULD NOT FIND ANY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21304352 ↗
• MalfunctionOct 10, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING AN ALL-INSIDE ANTERIOR CRUCIATE LIGAMENT SURGERY THE FLIP CUTTER WAS NOT STABLE AND FLIPPED BACK TO 3.5MM WHILE THE SURGEON PERFORMED THE 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 20417236 ↗
• MalfunctionSep 19, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN ALL INSIDE ANTERIOR CRUCIATE LIGAMENT PLASTY SURGERY THE DEVICE COULD NOT BE FLIPPED BACK AFTER THE RETROGRADE DRILLING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 20260980 ↗
• MalfunctionJun 25, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE TIP OF THE DEVICE BROKE OFF. THE DEVICE DID NOT BREAK INSIDE THE 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 19610546 ↗
• MalfunctionJun 19, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE WHOLE OUTER SHEATH CAME LOOSE RENDERING THE FLIPPING MECHANISM USELESS AND IT WAS NOT POSSIBLE TO STRAIGHTEN THE BLADE TO REMOVE IT. NO PART OF THE DEVICE BROKE OFF. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-1204AS-80). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570279 ↗
• MalfunctionMay 15, 2024Break; Break

  ON (B)(6) 2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT QTY.2 OF THE AR-1204AS-85 FLIPCUTTER BECAME STUCK ONCE FLIPPED AND WOULD NOT FULLY STRAIGHTEN BACK INTO POSITION. THIS WAS DISCOVERED DURING AN ACL ALL INSIDE PROCEDURE ON (B)(6) 2022. THE CASE WAS COMPLETED BY USING A THIRD AR-1204AS-85.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319849 ↗
• MalfunctionMay 15, 2024Break; Break

  ON (B)(6) 2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT QTY.2 OF THE AR-1204AS-85 FLIPCUTTER BECAME STUCK ONCE FLIPPED AND WOULD NOT FULLY STRAIGHTEN BACK INTO POSITION. THIS WAS DISCOVERED DURING AN ACL ALL INSIDE PROCEDURE ON (B)(6) 2022. THE CASE WAS COMPLETED BY USING A THIRD AR-1204AS-85.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319808 ↗
• MalfunctionMar 21, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PLASTY AFTER DRILLING, THE FLIPCUTTER COULD NO LONGER BE CLOSED IN THE JOINT AND THE MECHANISM JAMMED. THE INSTRUMENT COULD ONLY BE REMOVED BY APPLYING FORCE WITH A RASPATORY. 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 18951356 ↗
• MalfunctionMar 20, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PLASTY THE FLIPCUTTER COULD NOT BE FLIPPED BACK IN THE JOINT ANYMORE. THE SURGEON HAD TO USE FORCE AND A DIFFERENT DEVICE TO RETRACT THE CUTTER. 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 18943591 ↗
• InjuryMar 1, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ALL INSIDE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON THE (B)(6) 2024 THE TIP OF THE DEVICE BROKE OF WHILST REAMING THE FEMORAL TUNNEL. THE TIP COULD NOT BE RETRIEVED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. THE DAY AFTER ON THE (B)(6) 2024 A SECOND LOOK ARTHROSCOPY WAS DONE WITH FLUOROSCOPY AND THE TIP APPEARED TO BE INSIDE THE PCL. IT WAS NOT POSSIBLE TO RETRIEVE THE BROKEN OFF TIP DURING THE SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18819841 ↗
• InjuryFeb 19, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ALL INSIDE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE TIP OF THE DEVICE BROKE OF WHILST REAMING THE FEMORAL TUNNEL. THE TIP COULD NOT BE RETRIEVED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. THE DAY AFTER ON THE (B)(6) 2024 A SECOND LOOK ARTHROSCOPY WAS DONE WITH FLUOROSCOPY AND THE TIP APPEARED TO BE INSIDE THE PCL. IT WAS NOT POSSIBLE TO RETRIEVE THE BROKEN OFF TIP DURING THE SECOND SURGERY. ***UPDATE AVOE 07-FEB-2024 IT WAS FURTHER REPORTED THAT FOR NOW THE PATIENT WILL BE FOLLOWED UP IN 2 WEEKS WITH A NEW SERIES OF X-RAYS TO SEE IF THE FRAGMENT WILL MOVE. IT IS UNCERTAIN IF THERE ARE ANY OTHER CONSEQUENCES. THE SURGEON CONCURRED WITH 3 OTHER SURGEONS AND SAID THAT IF THE TIP IS INDEED EMBEDDED IN THE PCL THAT IT WILL MOST LIKELY CAUSE NO HARM OR PAIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 18730886 ↗
• MalfunctionJan 12, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING AN ALL-INSIDE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE FLIPCUTTER MECHANISM FAILED. IT WAS NOT POSSIBLE TO RETURN THE FLIPCUTTER TO 3.5 MM DIAMETER. THE TUNNEL WAS REAMED 8,5 MM DIAMETER ALL THE WAY THROUGH AND THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE USE OF A BUTTON EXTENDER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPON FOLLOW-UP, IT WAS CONFIRMED THAT THE INNER WORKINGS OF THE FLIPCUTTER BROKE. THE BLUE KNOB WAS MOVING BUT THE TIP WAS STUCK IN THE FLIPPED POSITION.

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

  MAUDE report 18502460 ↗
• MalfunctionOct 10, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT THE FLIP CUTTER BROKE OFF INSIDE THE PATIENT. 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 17908241 ↗
• MalfunctionMay 2, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1204AS-85 FLIPCUTTER II BROKE INTO TWO PIECES AFTER FLIPPING. THIS WAS DISCOVERED DURING RETRO DRILLING DURING A PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED WITH A NEW AR-1204AS-85 FLIPCUTTER II. ADDITIONAL INFORMATION RECEIVED ON 4/7/2023: THIS WAS DISCOVERED DURING AN ANTERIOR BANKART LABRAL REPAIR PROCEDURE. THE BROKEN FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES.

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

  MAUDE report 16852383 ↗
• MalfunctionNov 30, 2021Break

  ON 11/09/2021, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1204AS-85 FLIPCUTTER TIP WAS DAMAGED. THIS WAS DISCOVERED DURING USE IN A PROCEDURE ON (B)(6) 2021. THE FRAGMENT WAS REMOVED AND THE CASE WAS COMPLETED BY USING A NEW AR-1204AS-85.

  Patient problems: Insufficient Information

  MAUDE report 12896767 ↗
• MalfunctionJul 14, 2021Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE AR-1204AS-85, DEVICE BROKE WHILE DRILLING. THE BROKEN FRAGMENT WAS RETRIEVED AND THE CASE WAS COMPLETED BY USING A NEW AR-1204AS-85.

  Patient problems: Insufficient Information

  MAUDE report 12165173 ↗
• InjuryMay 30, 2019Break; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP, THAT DURING AN ACL REPAIR PROCEDURE, THE SURGEON DRILLED AND PREPPED THE TIBIA WITH NO ISSUE. UPON INSERTION OF THE FLIPCUTTER, AR-1204AS-85, INTO THE JOINT, THE SURGEON NOTICED THAT THE TIP WAS BENT AND BROKEN. THE SURGEON HAD TO BEND AND BREAK THE FLIPCUTTER TO GET IT REMOVED FROM THE TIBIA. ALL THE PIECES WERE REMOVED AND THE CASE WAS COMPLETED USING AN AR-1897S GUIDE WIRE SET , AR-1208L, 8MM CANNULATED DRILL AND AR1209L, 9MM CANNULATED DRILL. ADDITIONAL INFORMATION PROVIDED 5/8/2019: ALL FRAGMENTS WERE REMOVED FROM THE ORIGINAL DRILL HOLE WITHOUT HAVING TO CREATE AN UNPLANNED INCISION. WHEN THE SURGEON SWITCHED TO THE AR-1897S, HE HAD TO DRILL A FULL TUNNEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8654966 ↗
• InjuryJul 16, 2018Material Twisted/Bent

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, THE SURGEON WAS USING THE 8.5MM FLIPCUTTER TO DRILL THE FEMORAL TUNNEL AND THE TIP OF THE FLIPCUTTER BENT DURING DRILLING. THE FLIPCUTTER WAS DRILLED OUT. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION OBTAINED: A FULL TUNNEL WAS DRILLED AND IN INTERFERENCE SCREW WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7690758 ↗