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

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00888867004115), received between Dec 16, 2016 and Mar 17, 2026 — classified as 12 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Break” (29 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Break

  IT WAS REPORTED THAT DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY, THE TIP OF THE FLIPCUTTER BROKE OFF. THE BROKEN PIECES 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 24616082 ↗
• MalfunctionMar 17, 2026Break

  IT WAS REPORTED THAT DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY, THE TIP OF THE FLIPCUTTER BROKE OFF. THE BROKEN PIECES 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 24615967 ↗
• MalfunctionOct 16, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE FLIPCUTTER MECHANISM DIDNT WORK WHILE MAKING THE TBIAL NOTCH AND THE SURGEON WAS NOT ABLE TO FLIP IT INSIDE THE KNEE. THE FILPCUTTER WAS PULLED OUT OF THE KNEE INTACT AND WAS REPLACED BY NEW ONE. THE SURGERY ENDED GOOD WITH NO DAMAGE TO 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 23308997 ↗
• MalfunctionSep 12, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY WHILE DRILLING THE TIBIAL TUNNEL THE HEAD OF THE DRILL BROKE OFF INSIDE THE KNEE. THE BROKEN PART WAS RETRIEVED ARTHROSCOPICALLY AND A NEW FLIPCUTTER WAS USED TO FINISH THE SURGERY SUCCESSFULLY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199947 ↗
• MalfunctionAug 12, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY AND OSTEOTOMY, AFTER INSERTION INTO THE TISSUE, THE DRILLING TIP OF THE RETROGRADE DRILL BROKE OFF. 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 19962698 ↗
• MalfunctionJun 19, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A KNEE CX PROCEDURE, WHEN THE SURGEON WAS TRYING TO PIERCE THE TIBIA, THE FLIPCUTTER, AR-1204AF-100, MADE A STRANGE SOUND AND STOPPED WORKING. THE CASE WAS COMPLETED BY USING AR-1204AF-100 WITHOUT FURTHER ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 19567008 ↗
• MalfunctionJun 4, 2024Mechanical Jam; Mechanical Jam

  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, (B)(6) 2021 -SAC FAILURE CAN'T INSERT FIRST BLADE AND AFTER SECOND ONE INTO THE TUNNEL BECAUSE BLADE DIDN¿T WORK.

  Patient problems: Insufficient Information

  MAUDE report 19460093 ↗
• MalfunctionMay 23, 2024Mechanical Problem; Mechanical Problem

  ON07/06/2022, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA (B)(4) THAT A AR-1204AF-100 FLIPCUTTER DOES NOT WORK. THIS OCCURRED ON (B)(6) 2022 DURING A KNEE ARTHROSCOPY + ACL + PCL. THE CASE WAS COMPLETED. THERE WAS NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19385797 ↗
• MalfunctionMay 20, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE FINS DID NOT DEPLOY AT THE TIME OF DRILLING IN A RETROGRADE MANNER. A NEW DEVICE WITH THE SAME REFERENCE WAS USED TO FINISH THE SURGERY SUCCESSFULLY. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE SWIT 30-AUG-2021: IT WAS IMPOSSIBLE TO DEPLOY THE BLADE CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350363 ↗
• MalfunctionApr 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY AFTER INSERTION INTO THE TISSUE, THE DRILLING TIP OF THE RETROGRADE DRILL FELL OUT. 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 18-MAR-2024: IT WAS CONFIRMED THAT ALL FRAGMENTS OF THE DEVICE WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014224 ↗
• MalfunctionJan 11, 2024Break; Material Fragmentation; Break; Material Fragmentation

  ON 12/18/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE THAT AN AR-1204AF-100 FLIPCUTTER II BROKE IN THREE PIECES WHEN THE SURGEON TRIED TO DRILL THE TIBIA BONE SOCKET. ALL THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS COMPLETED USING ANOTHER AR-1204AF-100 FLIPCUTTER II. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2023. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18494772 ↗
• MalfunctionSep 26, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1204AF-100 FLIPCUTTER BLADE BROKE OFF. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. THE PIECE OF THE FLIPCUTTER WAS RETRIEVED AND ANOTHER FLIPCUTTER WAS OPENED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816926 ↗
• MalfunctionJul 3, 2023Break; Break

  ON 06/07/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1204AF-100 FLIPCUTTER® II TIP BROKE. THIS OCCURRED DURING A CASE WHEN DRILLING THE TIBIAL TUNNEL THE FLIPCUTTERSTIP BROKE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 17248133 ↗
• InjuryJun 19, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1204AF-100 FLIP CUTTER II HAD AN ISSUE. DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2023, THE SURGEON USED AN AR-1204AF-100 FLIP CUTTER II WITH AN UNKNOWN LOT NUMBER AND COMPLETED THE CASE SUCCESSFULLY. A COUPLE OF WEEKS AFTER THE SURGERY, THE PATIENT HAD A FOLLOW-UP APPOINTMENT, X-RAYS WERE TAKEN, AND A FRAGMENT OF THE FLIP CUTTER II WAS DETECTED INSIDE THE PATIENT'S KNEE. ON (B)(6) 2023, REVISION SURGERY WAS PERFORMED BY THE SAME SURGEON. THE FRAGMENT OF THE AR-1204AF-100 FLIP CUTTER II WAS REMOVED SUCCESSFULLY WITHOUT HAVING TO PERFORM A RECONSTRUCTION SURGERY, THE ACL PROCEDURAL OUTCOME WAS NOT IMPACTED BY THE FRAGMENT REMOVAL. TO DATE, THE PATIENT IS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17152381 ↗
• MalfunctionMay 30, 2023Break; Break

  ON 05/08/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1204AF-100 FLIP CUTTER BROKE. THIS OCCURRED DURING A CASE, THE FLIP CUTTER BROKE IN THE BUTTON. THE FLIP CUTTER WAS SWITCHED OUT AND THE CASE WAS COMPLETED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17021646 ↗
• InjuryMay 25, 2023Break; Break

  IT WAS REPORTED THAT DURING A RIGHT KNEE LIGAMENTOPLASTY SURGERY THE DEVICE BROKE IN THE PATIENT. THE DEVICE WAS RECOVERED IN THE JOINT BUT THIS ERROR LED TO A LENGTHENING OF THE DURATION OF THE INTERVENTION OF ABOUT +1 HOUR. 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 17007383 ↗
• MalfunctionMay 22, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE MATERIAL BROKE WHILE IT WAS USED BY 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: Insufficient Information

  MAUDE report 16973119 ↗
• MalfunctionOct 4, 2022Break

  ON 9/30/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1204AF-100 FLIPCUTTER® II, 10 MM HAD AN ISSUE. WHEN CARRYING OUT THE PROCEDURE ON (B)(6) 2022, THE TIP OF THE FLIPCUTTER WAS BROKEN, IT WAS POSSIBLE TO SEE AS IF IT HAD BEEN REMOVED AND LATER THE PART WITH WHICH THE RETRO-PERFORATION WAS CARRIED OUT WAS DISASSEMBLED. THIS WAS DISCOVERED DURING USE WITH NO CASE/PATIENT INVOLVEMENT AND NO PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538147 ↗
• MalfunctionAug 1, 2022Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE BROKE IN THE FEMORAL TUNNEL RESULTING IN THE PRESENCE OF METALLIC FOREIGN MATERIAL IN THE JOINT. THE BROKEN PARTS WERE REMOVED UNDER ARTHROSCOPY AND THE OPERATING TIME INCREASED. 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 21-JUL-2022: IT WAS CONFIRMED THAT THE SHAFT OF THE DEVICE BROKE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15137875 ↗
• MalfunctionAug 1, 2022Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE BROKE IN THE FEMORAL TUNNEL RESULTING IN THE PRESENCE OF METALLIC FOREIGN MATERIAL IN THE JOINT. THE BROKEN PARTS WERE REMOVED UNDER ARTHROSCOPY AND THE OPERATING TIME INCREASED. 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 21-JUL-2022: IT WAS CONFIRMED THAT THE SHAFT OF THE DEVICE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15137853 ↗
• MalfunctionFeb 28, 2022Device Slipped

  IT WAS REPORTED THAT DURING A DIDT PROCEDURE THE BLADES CAME OFF THE TWO FLIPCUTTER AND THE SURGEON RECOVERED THE BLADES. 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 13621126 ↗
• MalfunctionDec 13, 2021Break

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1204AF-100 FLIP CUTTER BROKE DURING AN ACL RECONSTRUCTION CASE. WHEN RETRO-DRILLING THE FEMORAL TUNNEL THE TIP OF THE FLIP CUTTER BROKE INTO 3 SEPARATE PIECES. THE SURGEON IS VERY FAMILIAR WITH THE DEVICE AND MADE SURE TO START THE FLIP CUTTER OFF OF THE FEMORAL WALL. THE PATIENTS BONE QUALITY WAS VERY GOOD. ALL 3 METAL PIECES FROM THE TIP OF THE DEVICE WAS RETRIEVED FROM THE PATIENT. A NEW FLIP CUTTER WAS OPENED AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983899 ↗
• MalfunctionDec 7, 2021Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE BROKE DURING THE BONE PERFORATION. THE BROKEN 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 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 12951583 ↗
• MalfunctionNov 22, 2021Break; Use of Device Problem

  IT WAS REPORTED THAT DURING A KNEE LIGAMENTOPLASTY WHILE DRILLING THE BLIND TUNNEL IN THE FEMUR THE DEVICE BROKE. A SECOND DEVICE WAS USED AND ALSO FAILED. THE SURGEON WAS ABLE TO REMOVED THE PRODUCE 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. 03-NOV-2021 UPDATE: FURTHER INFORMATION WAS PROVIDED THAT THE TIP OF THE DEVICE BROKE OFF.

  Patient problems: Insufficient Information

  MAUDE report 12853123 ↗
• MalfunctionNov 22, 2021Break

  IT WAS REPORTED THAT DURING A KNEE LIGAMENTOPLASTY WHILE DRILLING THE BLIND TUNNEL IN THE FEMUR THE DEVICE BROKE. A SECOND DEVICE WAS USED AND ALSO FAILED. THE SURGEON WAS ABLE TO REMOVED THE PRODUCE 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. ON 03-NOV-2021 UPDATE: FURTHER INFORMATION WAS PROVIDED THAT THE TIP OF THE DEVICE BROKE OFF.

  Patient problems: Foreign Body In Patient

  MAUDE report 12853099 ↗