Arthrex® AR-1204AS-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00888867004283), received between May 10, 2017 and Jul 31, 2026 — classified as 7 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (27 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50103373 ↗
• MalfunctionFeb 5, 2026Break

  ON 14-JAN-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1204AS-100 FLIPCUTTER TIP BROKE WHEN THE DRILL WAS PRESSED AGAINST THE BONE AND TURNED. THE PROCEDURE WAS COMPLETED BY USING A 9.5MM DRILL, ONE SIZE SMALLER. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267866 ↗
• InjuryJan 26, 2026Break; Detachment of Device or Device Component

  ON 11 JANUARY 2026 A DISTRIBUTOR REPORTED, VIA EMAIL, THAT THE FLIP-CUTTER SLEEVE OF AR-1204AS-100 LOT/SERIAL # (B)(6) HAD DETACHED FROM THE BLADE SHAFT, LEAVING THE BLADE INSIDE THE JOINT WITH NO ABILITY TO FLIP IT BACK TO 3.5 MM. THE ISSUE WAS DETECTED DURING A KNEE ACL QUADLINK PROCEDURE. THE SURGEON CREATED A FULL TIBIAL TUNNEL TO RETRIEVE THE BROKEN FLIP-CUTTER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO FRAGMENTS RETAINED IN THE PATIENT¿S BODY.

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

  MAUDE report 24180114 ↗
• MalfunctionAug 18, 2025Break; Break

  ON 31ST JULY 2025, IT WAS REPORTED BY AN DISTRIBUTOR VIA EMAIL THAT FOR 1 UNIT OF AR-1204AS-100, FLIPCUTTER¿ II, SHORT 10.0 MM, THE FLIPCUTTER BROKE WHILE THE SURGEON WAS ROTATING IT DURING THE PROCEDURE. THIS WAS DETECTED DURING AN ARTHROSCOPIC ACL+ PCL RECONSTRUCTION ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING A NEW AR-1204AS-100. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827333 ↗
• MalfunctionAug 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN REVISION OF AN ANTERIOR CRUCIATE LIGEMANT RECONSTRUCTION SURGERY THE FLIPCUTTER FAILED TO STRAIGHTEN AFTER REAMING THE FEMORAL TUNNEL. 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 22814598 ↗
• MalfunctionMay 20, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION HAS BEEN RECEIVED ON 5/20/2025: AN AUTOGRAFT QUAD TENDON ACL RECONSTRUCTION PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, A DELAY OF APPROXIMATELY 10 MINUTES WAS REPORTED DUE TO IDENTIFIED ISSUES. HOWEVER, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED BEYOND THE EXPECTED DURATION, WITH THE PATIENT REMAINING UNDER FOR AN ADDITIONAL 10 MINUTES. NO SURGICAL INSTRUMENTS OR IMPLANTS BROKE, AND NO FRAGMENTS WERE ENCOUNTERED DURING THE PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22052849 ↗
• MalfunctionFeb 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ALL-INSIDE ANTERIOR CRUCIATE RECONSTRUCTION SURGERY THE FEMUR WAS DRILLED WITH A DRILL WITHOUT ANY PROBLEMS, BUT DURING FURTHER DRILLING ON THE TIBIA, A METAL PIECE FELL OUT INTO THE KNEE WHEN THE JOINT WAS OPENED, AND THE SURGEON REMOVED IT OUTSIDE THE JOINT. 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 21470685 ↗
• MalfunctionNov 1, 2024Break; Break

  ON 11/7/2024 ADDITIONAL INFORMATION WAS PROVIDED BY THE SALES REPRESENTATIVE WHO STATED THAT THE SURGEON WHO IS WELL VERSED IN FLIPCUTTER HAD ONE BREAK. IN TYPICAL DRILLING FASHION HE DRILLED ON FORWARD FULL SPEED. DURING TIBIAL DRILLING DURING AN ACL PROCEDURE THE FLIPCUTTER 2 BROKE LEAVING THE OUTER SHEATH AND FLIP IN THE JOINT AND THE INNER FLIPPING DEVICE AND BLUE TAB ATTACHED TO THE DRILL. BECAUSE THE FLIPPING MECHANISM WAS REMOVED, WE WERE ABLE TO USE A GRASPER AND STRAIGHTEN THE FLIP WITHOUT ANY PATIENT HARM. THE FLIPCUTTER IS BEING WASHED AND PLAN IS TO SEND TO ARTHREX. ATTACHED WERE 2 PHOTOS OF THE DISPOSABLE FLIP CUTTER AND THE REFERENCE NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20587356 ↗
• MalfunctionJun 8, 2024Activation Failure; Activation Failure

  ON 10/31/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-1204AS-100 FLIPCUTTER IS JAMMED. THIS OCCURRED DURING USE ON 10/24/2022 WHEN THE SURGEON COULD NOT FLIP THE END STRAIGHT ENOUGH TO GET OUT OF THE 3.5 STEP SLEEVE, HE ENDED UP REMOVING BOTH THE SLEEVE AND THE FLIP CUTTER. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19493117 ↗
• MalfunctionJun 6, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT ALL INSIDE PLASTIC SURGERY IT WAS NOT POSSIBLE TO FLIP THE BLADE BACK. 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 19476606 ↗
• MalfunctionJun 4, 2024Mechanical Jam; Mechanical Jam

  ON 10/25/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1204AS-100 FLIPCUTTER II DRILL TIP GOT STUCK AND COULD NOT BE FLIPPED DOWN. THIS WAS DISCOVERED DURING AN ACL/PCL RECONSTRUCTION, PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19460391 ↗
• MalfunctionMay 24, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE FLIPPING MECHANISM DID NOT WORK AFTER DRILLING INTO THE TIBIA. 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-95). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391857 ↗
• MalfunctionMay 21, 2024Break; Break

  IT WAS REPORTED ON 10/14/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1204AS-100 FLIPCUTTER INNER SHEATH BROKE OFF THE INNER DRILL. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19357842 ↗
• MalfunctionApr 9, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY IT WAS NOTICED THAT THE FLIPCUTTER II 10MM SHORT (AR-1204AS-100) WITH LOT NUMBER 3201133523 SHED METAL RESIDUE. THIS WAS FIRST NOTICED AFTER THE RETROGRADE DRILLING OF THE FEMORAL TUNNEL. BEFORE DRILLING THE TIBIAL TUNNEL, THE FLIPCUTTER WAS CLEANED AND THE METAL RESIDUE WAS NOTICED. THE FLIPCUTTER MECHANISM WAS STILL FULLY FUNCTIONAL AND DURING SURGERY NOTHING OUT OF THE ORDINARY WAS DONE WITH THE DEVICE. THE SURGERY WAS CONTINUED WITH THE SAME DEVICE AND THERE WERE NO FURTHER COMPLICATIONS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 08-APR-2024: NO METAL RESIDUE REMAIN INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19072517 ↗
• MalfunctionMar 11, 2024Break; Break

  UPDATE SWIT 11-MAR-2024: THE SURGEON RECOVERED THE FRAGMENTS AND USED A NEW WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18873588 ↗
• MalfunctionNov 1, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1204AS-100 FLIPCUTTER II HAD AN ISSUE. THE SHAFT "SHEATH" BROKE OFF THE HANDLE DURING DRILLING. THE CASE WAS COMPLETED BY REMOVING THE COMPLAINT DEVICE WITH NO FRAGMENTS LEFT INSIDE THE PATIENT AND USING ANOTHER AR-1204AS-100 FLIPCUTTER II WITH A TWO MINUTE DELAY IN THE PROCEDURE. THIS WAS DISCOVERED DURING A ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18046016 ↗
• InjuryOct 16, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION THE MECHANISM STOPPED WORKING WHILE DRILLING THE TIBIA AND THE FLIP CUTTER DID NOT FLIP BACK ANYMORE. DUE TO THIS FAILURE, A COMPLETE TUNNEL HAD TO BE DRILLED AND THE SURGEON USED AN EXTENDER BUTTON TO FINISH THE PROCEDURE SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 17940124 ↗
• MalfunctionSep 12, 2023Break; Break

  ON(B)(6) 2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT (2) AR-1204AS-100 FLIPCUTTER¿ II TIPS BROKE OFF. THIS OCCURRED DURING A REVISION ACL SURGERY, WHEN RETRO DRILLING, THE TIPS OF 2 OF THE FLIPCUTTERS BROKE OFF. THE FEMORAL TUNNEL WAS IN A NEW LOCATION COMPARED TO THE ORIGINAL FEMORAL TUNNEL. THE SOCKETS WERE EVENTUALLY SUCCESSFULLY DRILLED WITH THE 3RD FLIPCUTTER. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Failure of Implant

  MAUDE report 17728052 ↗
• MalfunctionJun 22, 2023Break; Break

  ON 6/12023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1204AS-100 FLIPCUTTER II BROKE. THIS WAS DISCOVERED WHILE RETRO DRILLING THE TIBIA DURING AN ALC PROCEDURE ON (B)(6) 2023. THE BROKEN FRAGMENT WAS RETRIEVED, AND THE CASE WAS COMPLETED USING ANOTHER AR-1204AS-100 FLIPCUTTER II.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17181962 ↗
• MalfunctionDec 2, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1204AS-100 FLIPCUTTER II BLADE BROKE OFF INSIDE THE PATIENT. THIS WAS DISCOVERED WHILE RETRO DRILLING DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 15905689 ↗
• MalfunctionAug 29, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1204AS-100 FLIPCUTTER BROKE. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE JOINT SPACE.

  Patient problems: Insufficient Information

  MAUDE report 15310714 ↗
• MalfunctionApr 18, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-1204AS-100 FLIPCUTTER II BLADE BROKE. THIS WAS DISCOVERED DURING A CASE AND BROKE IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14136951 ↗
• MalfunctionJan 11, 2022Break

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE TIP OF AN AR-1204AS FLIPCUTTER BROKE OFF. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THIS WAS DISCOVERED DURING USE IN A PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED BY OPENING A NEW AR-1204AS-100.

  Patient problems: Insufficient Information

  MAUDE report 13225315 ↗
• MalfunctionNov 22, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1204AS-100 FLIPCUTTER OUTER SHEATH BROKE INSIDE. THIS WAS DISCOVERED DURING A PROCEDURE AND PATIENT WAS AFFECTED.

  Patient problems: Insufficient Information

  MAUDE report 12853648 ↗
• MalfunctionAug 3, 2021Break

  IT WAS REPORTED THAT DURING A GRAFTLINK ACL PROCEDURE, WHEN THE SURGEON DRILLED IN THE TIBIAL AND FLIPPED TO THE REAMER, BEFORE HE COULD START DRILLING, THE SHAFT OF THE FLIPCUTTER, AR-1204AS-10, BROKE OFF IN THE SURGEONS HAND. THE SURGEON SPENT 30+ MINUTES TRYING TO GET THE FLIPPED END OF THE FLIPCUTTER OUT OF THE TUNNEL AND JOINT. ALL FRAGMENTS WERE RETRIEVED AND THE CASE WAS COMPLETED BY USING A NEW AR-1204AS-10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267370 ↗