Arthrex® AR-1288RTT-FC3Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00888867357624), received between Sep 14, 2021 and Mar 17, 2025 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1288RTT-FC3 FIBERTAG TIGHTROPE WITH FLIPCUTTER III HAD AN ISSUE DURING A QUADRICEPS ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025. WHEN THE SURGEON WAS USING THE IMPLANT AND SUTURING IT, THE TAPE UNRAVELED. ALL SUTURES WERE CUT AND REMOVED TOGETHER WITH THE IMPLANT FROM THE PATIENT. NOTHING BROKE INSIDE THE PATIENT, AND THERE WAS NO HARM. THE COMPLAINT DEVICE WAS DISCARDED, AND NO PICTURES WERE TAKEN. AN AR-1588RTT ACL FIBERTAG TIGHTROPE IMPLANT WITH AN UNKNOWN LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE CASE WAS DELAYED FOR 5 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619494 ↗
• MalfunctionJun 25, 2024Break; Break

  ON 05/30/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-1288RTT-FC3 FIBERTAG TIGHTROPE WITH FLIPCUTTER III BROKE OFF WHILE USED. THIS OCCURRED DURING AN ACL RECONSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN ASKED. ADDITIONAL INFORMATION RECEIVED ON 6/7/2024: ALL THE BROKEN FRAGMENTS WERE REMOVED FROM INSIDE THE PATIENT. AT THIS TIME IT IS UNKNOWN WHICH PRODUCTS WERE USED TO COMPLETE THE SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 19604424 ↗
• MalfunctionJun 21, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 05/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT THE BLADE OF A FLIPCUTTER III FROM AN AR-1288RTT-FC3 FIBERTAG TIGHTROPE IMPLANT SYSTEM GOT STUCK IN A DEPLOYED POSITION INSIDE THE PATIENT'S JOINT. THE GUIDE HAD TO BE REMOVED IN CONJUNCTION WITH THE FLIPCUTTER III, LEAVING A LARGER BONE TUNNEL THAN WHAT WAS ORIGINALLY REAMED. ADDITIONAL INFORMATION RECEIVED ON 5/29/2024: THIS WAS DISCOVERED DURING AN ACL PROCEDURE ON (B)(6) 2024. A GUIDE HAMMERED OUT THE STUCK FLIPCUTTER, AND A NEW INDIVIDUAL AR-1204FF FLIPCUTTER III WAS USED TO COMPLETE THE REAMING PROCESS. REMOVING THE FLIPCUTTER TOOK AN EXTRA TEN MINUTES; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584837 ↗
• MalfunctionJun 19, 2024Break; Break

  ON 5/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE BLACK HANDLE OF THE FLIPCUTTER III FROM AN AR-1288RTT-FC3 FIBERTAG TIGHTROPE WITH FLIPCUTTER IMPLANT SYSTEM FELL APART WHILE RETRO DRILLING. BECAUSE OF THIS, THE BLADE OF THE FLIPCUTTER WAS UNABLE TO CLOSE ALL THE WAY. EVERYTHING WAS REMOVED FROM INSIDE THE PATIENT, AND THE CASE CONTINUED. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19569641 ↗
• MalfunctionJun 13, 2024Retraction Problem; Retraction Problem

  ON 05/02/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1288RTT-FC3 FIBERTAG TIGHTROPE WITH FLIPCUTTER III BLADE WOULD NOT CLOSE. THIS OCCURRED DURING A CASE, THE OBLONGS CUT OUT WAS OFF CENTER, AND WOULD NOT ALLOW FOR THE BLADE TO FULLY CLOSE AFTER RETRO REAMING. THEY MANUALLY CLOSED THE BLADE WITH A GRASPER IN THE JOINT HOWEVER IT WOULD NOT CLOSE TO 3.5. THEY REMOVED THE FLIPCUTTER AND DRILL SLEEVE SIMULTANEOUSLY AND SHUTTLED THE FIBER STICK THROUGH THE BONE TUNNEL INSTEAD OF THE DRILL SLEEVE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531278 ↗
• MalfunctionMar 15, 2024Unintended Movement; Unintended Movement

  ON 03/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT (2) AR-1288RTT-FC3 FIBERTAG TIGHTROPE WITH FLIPCUTTER III HAD AN EXCESSIVE WOBBLE WHEN SPUN ON THE DRILL OUTSIDE OF THE JOINT. THIS OCCURRED DURING A QUAD AUTO ACL RECONSTRUCTION WHERE THE SURGEON DECLINED TO USE THEM, FEARING THE WOBBLE WOULD CREATE A TUNNEL LARGER THAN WHAT HE WANTED. THE CASE CONTINUED USING A FLIPCUTTER 2 TO COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 18914123 ↗
• MalfunctionMar 15, 2024Unintended Movement; Unintended Movement

  ON 03/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT (2) AR-1288RTT-FC3 FIBERTAG TIGHTROPE WITH FLIPCUTTER III HAD AN EXCESSIVE WOBBLE WHEN SPUN ON THE DRILL OUTSIDE OF THE JOINT. THIS OCCURRED DURING A QUAD AUTO ACL RECONSTRUCTION WHERE THE SURGEON DECLINED TO USE THEM, FEARING THE WOBBLE WOULD CREATE A TUNNEL LARGER THAN WHAT HE WANTED. THE CASE CONTINUED USING A FLIPCUTTER 2 TO COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 18914112 ↗
• MalfunctionFeb 19, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 1/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT THE FLIPCUTTER III FROM AN AR-1288RTT-FC3 FIBERTAG TIGHTROPE WITH FLIPCUTTER III WAS BENT AND FULL OF BONE DEBRIS, NOT ALLOWING FOR THE FLIPCUTTER TO CLOSE. THE SURGEON DRILLED INTO THE JOINT THROUGH THE FEMUR. THE FLIPCUTTER III WAS ADJUSTED TO AN 11 MM SIZE. THE SURGEON GOT THE FLIPCUTTER TO SPEED BEFORE PULLING INTO THE BONE. A 22 MM SOCKET WAS DRILLED AND WHEN THE FLIPCUTTER WAS BROUGHT BACK INTO THE JOINT, IT WOULD NOT CLOSE DUE TO THE BEING BENT AND HAVING BONE DEBRIS. THE FLIPCUTTER WAS CLAMPED SHUT WITH A GRASPER. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 2/6/2024: NOTHING BROKE INSIDE THE PATIENT. THE BLADE WAS CLAMPED SHUT, AND THE FLIPCUTTER WAS REMOVED FROM INSIDE THE PATIENT WITHOUT ANY ISSUES. THE REAMING PROCESS WAS COMPLETED USING A SHORT FLIPCUTTER III. ALL THE IMPLANTS FROM THE R-1288RTT-FC3 FIBERTAG TIGHTROPE KIT WERE USED. THE CASE WAS DELAYED ABOUT FIFTEEN MINUTES; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730501 ↗
• MalfunctionDec 15, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06404807 THAT THE TIP OF THE FLIPCUTTER III FROM AN AR-1288RTT-FC3 FIBERTAG TIGHTROPE WITH FLIPCUTTER III SNAPPED OFF AS SOON AS IT CAME IN CONTACT WITH THE FEMORAL WALL. THIS WAS DISCOVERED DURING A QUAD ACL PROCEDURE ON (B)(6) 2023. ALL THE BROKEN FRAGMENTS WERE REMOVED FROM INSIDE THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 11/22/2023: THE BROKEN FRAGMENTS WERE REMOVED USING A GRASPER, AND THE CASE WAS COMPLETED USING AN AR-1204FF FLIPCUTTER III. THE CASE WAS DELAYED FIVE MINUTES, AND THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340879 ↗
• MalfunctionSep 29, 2023Break; Break

  ON 9/1/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06021084 THAT AN AR-1288RTT-FC3 FIBERTAG TIGHTROPE WITH FLIPCUTTER III HAD AN ISSUE DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2023. WHEN THEY WENT TO DRILL, THE DRILL AT THE TIP OF THE FLIPCUTTER III BROKE OFF COMPLETELY ONCE IT TOUCHED THE BONE. THEY WERE ABLE TO RECOVER THE BROKEN DRILL BIT. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 9/6/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA PHONE: THIS OCCURRED DURING AN ACL RECONSTRUCTION PROCEDURE. A FLIPCUTTER II WITH AN UNKNOWN PART AND LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A 2-MINUTE CASE DELAY REPORTED, BUT NO ADVERSE EFFECT TO THE PATIENT. THE COMPLAINT DEVICE WAS DISCARDED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17847330 ↗
• InjuryJul 10, 2023Break; Break

  ON 06/08/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA PHONE THAT AN AR-1288RTT-FC3 TIGHTROPES FLIPCUTTER BLADE BROKE OFF. THIS WAS DISCOVERED DURING A CASE, BROKEN PORTION OF BLADE UNABLE TO BE REMOVED, ADDITIONAL SURGERY REQUIRED TO REMOVE PIECE. REVISION OCCURRED (B)(6) 2023 AND WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17286737 ↗
• MalfunctionJun 7, 2023Break; Break

  ON 05/10/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE TIP FORM A FLIPCUTTER III AN AR-1288RTT-FC3 FIBERTAG TIGHTROPE BROKE OFF DURING RETRO DRILLING. THE BROKEN FRAGMENTS WERE RETRIEVED, AND THE CASE WAS CONTINUED WITH A NEW DRILL. THIS WAS DISCOVERED DURING AN ACLR AND MENISCAL TRANSPLANT PROCEDURE ON (B)(6) 2023.

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

  MAUDE report 17078168 ↗
• MalfunctionMar 24, 2023Break; Break

  ON 03/06/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1288RTT-FC3 FIBERTAG TIGHTROPE WITH FLIPCUTTER III BROKE INTO PIECES. THIS OCCURRED DURING AN ACL RECONSTRUCTION ON (B)(6) 2023 WHEN GOING TO FLIP-CUT THE TUNNELS THE FLIP CUTTER HINGE BROKE OFF WHILE REAMING. ALL THE FRAGMENTS THAT WERE PRODUCED WERE RETRIEVED. THE CASE WAS COMPLETED USING AN AR-1204FF FLIPCUTTER.

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

  MAUDE report 16608875 ↗
• MalfunctionFeb 20, 2023Break

  ON 2/1/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE TIP OF FLIPCUTTER III FROM AN AR-1288RTT-FC3 FIBERTAG TIGHTROPE KIT, BROKE OFF. THE BROKEN TIP WAS TAKEN OUT OF THE PATIENT AND A NEW FLIPCUTTER II WAS OPENED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023.

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

  MAUDE report 16403921 ↗
• MalfunctionDec 12, 2022Break

  ON (B)(6) 2022 IT WAS REPORTED BY AN SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1288RTT-FC3 FIBERTAG TIGHTROPE SUTURE NEEDLE BROKE OFF DURING THE SECOND PASS THROUGH THE GRAFT. THIS WAS DISCOVERED DURING A QUAD TENDON AUTOGRAFT ACL RECONSTRUCTION ON (B)(6) 2022 AND WAS RESOLVED SUCCESSFULLY WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959003 ↗
• MalfunctionSep 19, 2022Break; Product Quality Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT QTY. 2 OF AN AR-1204FF FLIPCUTTER III HAD AN ISSUE. ONE WAS INCLUDED IN A 1288QIS-100 KIT, AND A PICTURE OF THE SECOND ONE WAS PROVIDED. THE PROPER TECHNIQUE WAS USED AND THEY BOTH SHATTERED. THEY WERE ABLE TO RECOVER ALL METAL PIECES FROM THE PATIENT AND THERE WAS NO NEGATIVE OUTCOME. THIS HAS BECOME A REOCCURRING ISSUE WITH THE FLIP CUTTER 3¿S. THIS WAS DISCOVERED DURING USE IN AN UNSPECIFIED PROCEDURE ON (B)(6) 2022 WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2022, THE SALES REPRESENTATIVE REPLIED VIA EMAIL AND STATED THE FOLLOWING INFORMATION. THIS EVENT OCCURRED DURING AN ACL RECONSTRUCTION PROCEDURE. ONE DEVICE WAS AN AR-1204FF FLIPCUTTER III, THE OTHER DEVICE, ALSO AN AR-1204FF FLIPCUTTER III, WAS INCLUDED IN AN AR-1288RTT-FC3 FIBERTAG TIGHTROPE WITH FLIPCUTTER III. BOTH DEVICES WERE DISCARDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15445871 ↗
• MalfunctionMay 3, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-1288RTT-FC3 FIBERTAG FLIPCUTTER BROKE DURING INSERTION. THIS WAS DISCOVERED DURING USE AND BROKE IN THE JOINT SPACE.

  Patient problems: Insufficient Information

  MAUDE report 14270791 ↗
• MalfunctionApr 4, 2022Break; Defective Device; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-1288RTT-FC3 FLIPCUTTER BROKE. THIS OCCURRED DURING A CASE AND BROKE INSIDE THE PATIENT. PER FACILITY: "IN AN ACL RECONSTRUCTION CASE THIS MORNING, THE FLIP CUTTER WE WERE USING BROKE RATHER AGGRESSIVELY - I WAS IN THE CASE AND CAN CONFIRM THAT THE FLIP CUTTER WAS BEING USED AS INDICATED AND IN THE PROPER WAY. WE HAVE NO EXPLANATION FOR WHY THIS HAPPENED OTHER THAN THE FACT THAT THE PRODUCT IS DEFECTIVE. BECAUSE OF THE NATURE OF THE BROKEN BLADE AND THE BENT TIP, WE ARE UNABLE TO REMOVE THE STEPPED BULLET FROM THE FLIP CUTTER (AR-1510FS-7)."

  Patient problems: Insufficient Information

  MAUDE report 13995305 ↗
• MalfunctionMar 7, 2022Break

  ON 02/14/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1288RTT-FC3 FIBERTAG TIGHTROPE WITH FLIPCUTTER III HAD AN ISSUE. DURING AN ACL RECONSTRUCTION ON (B)(6) 2022, WHEN DRILLING THE FEMORAL SOCKET, THE TIP OF THE FLIPCUTTER POPPED OFF WHEN THE CUTTING ADJUSTABLE END HIT BONE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. CONTINUED THE CASE WITH A NEW FLIPCUTTER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13684450 ↗
• MalfunctionJan 4, 2022Break; Separation Problem

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588RTT TIGHTROPE THAT CAME IN THE AR-1288RTT-FC3 FIBERTAG TIGHTROPE WITH FLIPCUTTER III KIT, BROKE AND SEPARATED FROM THE FIBERTAG. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. SURGEON OPENED ANOTHER AR-1588RTT FROM AN INDIVIDUAL PACK AND COMPLETED THE CASE WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 13154221 ↗
• MalfunctionNov 22, 2021Output Problem

  ON 11/05/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1288RTT-FC3 TIGHT-ROPE WITH FLIP CUTTER HAD AN ISSUE WITH THE FLIP-CUTTER III. WHEN IT MADE CONTACT WITH THE BONE IT CAME APART FROM THE TIP BACK TO THE MAIN SHAFT OF THE DEVICE. IT WAS REMOVED FROM THE PATIENT AND REPLACED IT TO COMPLETE THE CASE. THE PATIENT IS FINE TO DATE.

  Patient problems: Insufficient Information

  MAUDE report 12853760 ↗
• MalfunctionSep 14, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT WHILE THE SURGEON WAS USING AN AR-1288RTT-FC3, THE FLIPCUTTER III WITHIN THE KIT, BROKE WHEN ACTIVATING THE ¿REAMING/CUTTING¿ PORTION OF THE FLIPCUTTER. THE FRAGMENT WAS RETRIEVED AND THE CASE WAS COMPLETED BY USING A NEW FLIPCUTTER.

  Patient problems: Insufficient Information

  MAUDE report 12467691 ↗