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

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00888867004443), received between Sep 13, 2017 and Sep 8, 2026 — classified as 3 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (23 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50671021 ↗
• MalfunctionAug 27, 2026Break

  On 14th August 2026, it was reported by an Arthrex employee via email that for an AR-1204AS-95, FlipCutter¿ II, Short 9.5 mm, the blade tip of a 9.5 mm FlipCutter fractured during use. It was believed that the fracture occurred due to the patient's good bone quality and the drill being powered while the blade was in contact with the bone, resulting in concentrated stress at a single point. The fractured blade fragment was retrieved from the patient. This was detected during use in a ACL-QT procedure on (b)(6) 2026. The procedure was completed successfully by using a product with the same part number.No significant surgery delay reported. Nothing remains in the patient. No additional anesthesia administered to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50473406 ↗
• MalfunctionAug 13, 2025Break; Break

  ON 07/29/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1204AS-95 FLIPCUTTER TIP OF THE DEVICE BROKE OFF DURING THE SURGERY, AND FRAGMENTS FELL INTO THE PATIENT. THE SURGEON WAS UNABLE TO REMOVE ALL OF THE FRAGMENTS, AND SOME REMAIN INSIDE THE PATIENT. THE SURGERY WAS COMPLETED USING A NEW PRODUCT IN A DIFFERENT SIZE. THE PATIENT'S BONE QUALITY IS REPORTED TO BE HARD. NO REVISION SURGERY IS CURRENTLY PLANNED. THIS OCCURRED DURING USE IN AN ACL RECONSTRUCTION SURGERY CASE WITH NO PATIENT EFFECT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22797431 ↗
• MalfunctionFeb 26, 2025Break; Break

  ON 02/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1204AS-95 FLIPCUTTER II WAS STARTED OFF BONE AND FELL APART. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ALL FRAGMENTS WERE REMOVED AND IT WAS A MINOR DELAY TO GET A NEW FLIPCUTTER 2, BUT OTHERWISE THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21467610 ↗
• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE TIP OF THE FLIPCUTTER BROKE. 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 21273599 ↗
• MalfunctionMay 20, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE DEVICE DID NOT DETACH AND REMAINED IN OPEN POSITION IN MILLING MODE. 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. UPDATE AVOE 21-JUL-2022. IT WAS CONFIRMED THAT THE ERROR OCCURRED OUTSIDE OF THE PATIENT. UPDATE AVOE 05-AUG-2022. IT WAS FURTHER CONFIRMED THAT THE ERROR OCCURRED PRIOR TO USE OF THE DEVICE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352211 ↗
• MalfunctionMay 7, 2024Break; Break

  ON 04/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1204AS-95 FLIPCUTTER BROKE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264969 ↗
• MalfunctionMay 1, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE TIP OF BOTH FLIPCUTTERS BROKE DURING DRILLING THE FEMORAL TUNNEL. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE DIFFERENT PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. ***UPDATE SWIT 19-APR-2024: THE BROKEN PIECES WERE RETRIEVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19222960 ↗
• MalfunctionMay 1, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE TIP OF BOTH FLIPCUTTERS BROKE DURING DRILLING THE FEMORAL TUNNEL. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE DIFFERENT PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. ***UPDATE SWIT 19-APR-2024: THE BROKEN PIECES WERE RETRIEVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19222665 ↗
• MalfunctionApr 10, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, AFTER DRILLING USING THE AR-1204AS-95, LOT: 0191104949 FLIPCUTTER, THE SURGEON COULD NOT FLIP THE DEVICE TO BACK IT OUT. THE SURGEON USED A PROBE TO FLIP THE AR-1204AS-95, FLIPCUTTER AND THE DEVICE WAS REMOVED. THE CASE AS COMPLETED USING A DIFFERENT AR-1204AS-95 SAME LOT NUMBER WITH NO ADDITIONAL ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19081028 ↗
• MalfunctionOct 16, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE FLIP CUTTER 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 17939642 ↗
• MalfunctionMay 8, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-1204AS-95 FLIPCUTTER¿ II BROKE. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON 04/12/2023, IT WAS REPORTED THAT THE DEVICE DID BREAK INSIDE THE PATIENT, AND THE BROKEN FRAGMENT WAS RETRIEVED SUCCESSFULLY. THE PATIENT HAD NORMAL BONE QUALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16890655 ↗
• MalfunctionMar 6, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1204AS-95 FLIPCUTTER II BROKE OFF IN THE BONE SOCKET DURING RETRO DRILLING. THE SURGEON REMOVED THE BLADE FROM INSIDE THE PATIENT AND THE CASE WAS COMPLETED USING ANOTHER AR-1204AS-95 FLIPCUTTER II. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2023.

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

  MAUDE report 16484793 ↗
• MalfunctionDec 5, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-1204AS-95 FLIPCUTTER¿ IIS DURING RETRO DRILLING THE BLADE OF THE FLIPCUTTER BROKE OFF. THIS OCCURRED DURING USE, WITH NO PATIENT EFFECT REPORTED.

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

  MAUDE report 15914500 ↗
• MalfunctionMar 7, 2022Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT WHILE DRILLING SURGERY THE TIP OF THE DEVICE BROKE OFF. THE BROKEN PIECE WAS RETRIEVED OUT OF THE PATIENT. ACCORDING TO THE SURGEON 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 13684927 ↗
• MalfunctionJan 31, 2022Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIP OF THE DEVICE BROKE OFF DURING FEMORAL DRILLING. THE BROKEN PIECES 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 13396004 ↗
• MalfunctionJan 5, 2022Break

  ON 12/20/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1204AS-95 WAS BEING USED DURING A PROCEDURE. THE SURGEON DRILLED THE TIBIA AND ONCE IN THE JOINT, DEPLOYED THE FLIPCUTTER. HE PULLED BACK SLOWLY AND THE BLADE BROKE OFF IN THE JOINT. A GRASPER WAS USED TO REMOVE THE BROKEN PIECE AND AN AR-1204FF WAS OPENED AND USED TO COMPLETE THE TIBIA TUNNEL DRILLING WITH NO ADVERSE EFFECT TO THE PATIENT. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13167476 ↗
• MalfunctionOct 19, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT WHILE THE SURGEON WAS USING AN AR-1204AS-95 FLIPCUTTER, THE BONE WAS VERY HARD AND THE PIN SEPARATED FROM THE FLIPCUTTER. THIS WAS DISCOVERED DURING AN ACL PROCEDURE ON (B)(6) 2021. THE BROKEN FRAGMENT AND THE DEVICE WAS REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED BY USING A NEW AR-1204AS-95 AND RE-DRILLING THE SAME TUNNEL.

  Patient problems: Insufficient Information

  MAUDE report 12658455 ↗
• MalfunctionJul 20, 2021Break; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE DID NOT WANT TO FLIP BACK AFTER CREATING THE SOCKET, BECAUSE THE FLIPPING MECHANISM BROKE. INITIALLY NO PART OF THE DEVICE BROKE OFF BUT THE SURGEON HAD TO BREAK THE DEVICE TO PULL IT OUT OF THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12198197 ↗
• MalfunctionJun 28, 2021Break

  IT WAS REPORTED THAT DURING AN ACL ALLOGRAPH PROCEDURE, WHEN THE SURGEON WAS DRILLING THE FEMORAL TUNNEL, THE AR-1204AS-95, BROKE IN RETRO DRILLING HIGH IN THE NOTCH BEFORE TUNNEL WAS DRILLED. THE BROKEN FRAGMENT WAS RETRIEVED AND THE CASE WAS COMPLETED BY USING ANOTHER FLIP CUTTER.

  Patient problems: Insufficient Information

  MAUDE report 12076363 ↗
• MalfunctionJun 1, 2021Break

  IT WAS REPORTED THAT DURING A ACL RECONSTRUCTION PROCEDURE, AS THE SURGEON WAS PULLING BACK WITH THE FLIPCUTTER DEVICE FULLY DEPLOYED, THE CUTTER SNAPPED OFF IN THE PATIENT¿S FEMORAL SOCKET AND HAD TO BE REMOVED. THE CASE WAS COMPLETED BY USING A NEW AR-1204AS-95.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11912052 ↗
• MalfunctionApr 7, 2021Break

  IT WAS REPORTED THAT THE SURGEON WAS DRILLING AND A PIECE OF THE AR-1204AS-95 FLIPCUTTER II BROKE APART. ALL BROKEN PIECES WERE RETRIEVED BY THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11630017 ↗
• MalfunctionMar 2, 2021Break

  IT WAS REPORTED DURING AN ACL PROCEDURE THE FLIP-CUTTER BROKE WHEN IT WAS FLIPPED INSIDE THE JOINT. THERE WERE 3 TOTAL SMALL PIECES THAT HAD TO BE RETRIEVED. THE SURGEON FOUND ALL OF THE MISSING PIECES AND REMOVED THEM FROM THE PATIENT. ANOTHER FLIP-CUTTER WAS USED TO COMPLETE THE CASE. THERE NO FURTHER ISSUES AND THE PATIENT IS FINE TO DATE. THIS WAS A YOUNGER FEMALE PATIENT WITH HARD BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11398301 ↗
• InjuryApr 22, 2019Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL PROCEDURE AFTER THE DOCTOR DRILLED THE FIRST TUNNEL, THE AR-1204AS-95 FLIP CUTTER WAS STUCK IN THE OPEN POSITION. THE SURGEON REMOVED THE FLIP CUTTER BY SNAPPING THE TOP JAW, ALL PIECES WERE REMOVED. THE SECOND TUNNEL WAS DRILLED AND THE SAME ISSUE OCCURRED THE SURGEON DRILLED A FULL TUNNEL AND REMOVED THE FLIP CUTTER BY BREAKING THE TOP JAW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8535441 ↗
• InjuryApr 18, 2018Retraction Problem; Sticking

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, AFTER THE SURGEON ENTERED THE REAMED FEMUR WITH A 9.5 FLIPCUTTER, THE CUTTER DEPLOYED BUT WOULD NOT RETRACT. THE SALES REP RETRACTED THE FLIP CUTTER FOR REPOSITIONING AND STILL THE CUTTER WOULD NOT UNLOCK. THE SURGEON TRIED A MALLET TO LOOSEN THE BUTTON BY THE CHUCK WITH NO LUCK, THE SURGEON THEN PLACED THE TIBIAL GUIDE OVER THE FLIP CUTTER AND TRIED TO PULL ON IT. STILL, THE CUTTER WOULD NOT RETRACT. A KING FISHER WAS THEN USED TO TRY AND MANEUVER THE CUTTER TO RETRACT WITH NO LUCK. THE SURGEON CUT THE HANDLE TO TRY AND GET THE WIRE TO RELEASE WITH A WIRE CUTTER; RECHECKING AND REAMED BACK PULLING THE CUTTER OUT STILL IN THE LOCKED POSITION. FINALLY, THE SURGEON JUST YANKED THE CUTTER THE REST OF THE 7MM OUT OF THE FEMUR. THE CASE WAS THEN COMPLETED WITH A BUTTON EXTENDER AND THE SURGEON HAD TO MAKE THE INCISION A LITTLE BIT LONGER. THE BUTTON WAS SITTING FLUSH AND THERE WAS NO COMPROMISE. FOLLOW-UP INVESTIGATION: THE AR-1204AS-95 FLIPCUTTER DEVICE IS BEING RETURNED IN TWO PIECES: 1) THE FLIPPED BLADE AND SHAFT PORTION AND 2) THE BUTTON PORTION THAT FLIPS THE BLADE. REP STATES THE FLIPCUTTER WAS CUT JUST BELOW THAT JUNCT

  Patient problems: No Information

  MAUDE report 7439305 ↗