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

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867004252), received between Jun 21, 2017 and Feb 27, 2026 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE ALL-INSIDE ANTERIOR CRUCIATE LIGAMENT SURGERY, THE BLADE OF THE FLIPCUTTER COULD NO LONGER BE RETRACTED. 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 24470658 ↗
• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL ALL-INSIDE SURGERY THE TIP OF THE DRILL BROKE WHILE FLIPPING THE FLIPCUTTER BEFORE IT WAS DRILLING BACKWARDS. IT BROKE OFF DURING THE FLIPPING PROCESS. THE BROKEN OFF PIECE HAS BEEN 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 21110830 ↗
• MalfunctionJun 5, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE DEVICE HAD A MALFUNCTION. 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. 02-JUN-2022 UPDATE DW ONCE THE FLIPCUTTER WINGS WERE DEPLOYED TO MAKE THE TUNNEL, THE WINGS WOULD NOT FOLD BACK TO REMOVE THE IMPLANT. AFTER MULTIPLE ATTEMPTS, THE WINGS FINALLY FOLDED BACK BUT WE LOST AT LEAST 15 MINUTES OF THE OPERATING SCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19471725 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS REPORTED THAT THE SURGEON IDENTIFIED DURING THE TEST PHASE FOR A KNEE LIGAMENTOPLASTY THE TIP OF THE DEVICE HAD BROKEN OFF WHEN IT WAS DEPLOYED BEFORE IT WAS USED ON THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19453796 ↗
• MalfunctionMay 23, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE COULD NOT BE "FOLDED" FOR RETRACTION. NO PART OF THE DEVICE BROKE OFF. 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. UPDATE AVOE 10-MAY-2023: IT WAS FURTHER REPORTED THAT THE DRILL COULD NOT BE PROPERLY FOLDED BACK TO THE ORIGINAL POSITION AFTER USE, WHICH MADE IT DIFFICULT TO REMOVE THE INSTRUMENT THROUGH THE DRILL CHANNEL. IT WAS DRILLED WITH THE DEVICE IN A STRAIGHT POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19383298 ↗
• MalfunctionFeb 14, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 01/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-1204AF-85 FLIPCUTTER® II WAS GETTING HUNG UP ON THE DRILL SLEEVE. THIS OCCURRED DURING AN ACL PROCEDURE WHERE THE FLIPCUTTER® II WAS DRILLED INTO THE LATERAL FEMORAL CONDYLE UTILIZING THE ACL POINT TO POINT GUIDE AND 3.5 DRILL SLEEVE. THE FLIPCUTTER® II WAS THEN OPENED TO ITS 8.5MM DIAMETER AND THE SOCKET WAS RETRO-DRILLED TO APPROXIMATELY 27MM UNTIL CONTACTING THE 7MM STEP ON THE DRILL SLEEVE. THE FLIPCUTTER® II WAS THEN TURNED BACK TO WHAT THEY THOUGHT WAS 3.5MM BUT WHEN ATTEMPTING TO REMOVE THE FLIPCUTTER® II IT WAS GETTING HUNG UP ON THE DRILL SLEEVE. THEY COULD NOT GET THE FLIPCUTTER® II OUT OF THE SLEEVE AND HAD TO MANUALLY FORCE IT OUT OF THE BONE. A NEW FLIPCUTTER® II WAS OPENED FOR TIBIAL DRILLING AND IT APPEARED THAT THE BLADE ON THE FLIPCUTTER® II HAD BENT JUST BARELY RESTRICTING IT FROM BEING REMOVED FROM THE DRILL SLEEVE.

  Patient problems: Insufficient Information

  MAUDE report 18702285 ↗
• MalfunctionApr 17, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE BLADE OF THE FLIPCUTTER BROKE OFF WHILE RETROGRADE DRILLING. 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 16752182 ↗
• MalfunctionJun 6, 2022Break

  ON 05/23/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT THE TIP OF THE AR-1204AF-85 FLIPCUTTER BROKE WHEN THE SURGEON WAS ROTATING THE TURNING DRILL INTO THE TIBIAL CANAL. THE BROKEN PIECE WAS RETRIEVED. THIS WAS DISCOVERED DURING A ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022. THE CASE WAS COMPLETED BY USING A NEW AR-1204AF-85 DIFFERENT LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14603857 ↗
• MalfunctionMay 9, 2022Material Fragmentation

  IT WAS REPORTED THAT DURING A LIGAMENTOPLASTY THE TIP OF THE FLIPCUTTER BROKE INTO SEVERAL PIECES. THEY MANAGED TO RECOVER ALL THE PIECES FROM 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 14336805 ↗
• MalfunctionOct 26, 2021Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A ALL INSIDE KNEE ARTHROSCOPY WITH AN FLIPCUTTER THE DEVICE BROKE OFF INSIDE THE JOINT. THE SURGEON REPORTED THAT THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DRILL AND A TRANSTIBIAL FULL TUNNEL DRILLING.

  Patient problems: Foreign Body In Patient

  MAUDE report 12696466 ↗
• InjuryJun 30, 2017Break; Detachment Of Device Component

  IT WAS REPORTED VIA FDA MEDWATCH LETTER (MW5069607) THAT DURING A POSTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY OF THE RIGHT KNEE THE SURGEON WAS USING THE ARTHREX FLIPCUTTER II, 8.5 MM, WHEN A METAL PIECE BROKE-OFF IN THE KNEE. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE METAL PIECE WITH USE OF FLUOROSCOPY AND ARTHROSCOPE VISUALIZATION. THE SURGEON WAS UNABLE TO RETRIEVE AND REMOVE THE METAL PIECE BROKEN FROM THE FLIPCUTTER. ADDITIONAL INFORMATION RECEIVED 6/28/2017: THE FACILITY HAS CONFIRMED THAT THE DEVICE HAS BEEN RETAINED. THE FACILITY POLICY REQUIRES THAT REPORTABLE DEVICE ISSUES ARE TO BE RETAINED AT THE FACILITY. IT WILL NOT BE RETURNED TO ARTHREX FOR EVALUATION, BUT IS AVAILABLE TO EVALUATE ON SITE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6680683 ↗
• InjuryJun 22, 2017Break; Difficult to Remove

  IT WAS REPORTED THAT DURING DRIVING IN OF THE SCREW, THE TIP OF THE SCREWDRIVER BROKE INSIDE THE SCREW. IT WAS NOT POSSIBLE TO REMOVE THE BROKEN PIECE. ADDITIONAL INFORMATION OBTAINED 06 JUN 2017: DATE OF EVENT WAS (B)(6) 2017 THE PATIENT IS FINE AND THERE ARE NO CONSEQUENTIAL DAMAGES FOR THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6661152 ↗
• InjuryJun 21, 2017Break

  IT WAS REPORTED THAT THE BLADE OF THE FLIP CUTTER BROKE DURING A VKB (VORDERES KREUZBAND = ACL) ALL INSIDE SURGERY. FRAGMENT COULDN'T BE REMOVED FROM PATIENT'S BODY, SURGERY WAS SUCCESSFULLY FINISHED WITH THIS FLIP CUTTER. ADDITIONAL INFORMATION RECEIVED FROM ARTHREX SWISS ON JUNE 09: AS PER THE SURGEON, THE BROKEN CUTTER IS FIXED INSIDE THE DRILL TUNNEL AND CANNOT BE RETRIEVED WITHOUT FURTHER DAMAGE. ACCORDING TO THE SURGEON, THERE IS NO RISK FOR THE FRAGMENT TO WANDER AROUND INSIDE THE BODY. THE POST-OP PROCESS IS NORMAL, THE PATIENT IS DOING FINE. THE PATIENTS FEMORAL AND TIBIAL BONE WAS IMMENSELY HARD.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6656268 ↗