Arthrex® AR-1288RTT2-FC3Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888867430341), received between Sep 13, 2024 and Apr 8, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Break

  ON 16-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE FLIPCUTTER III DRILL INCLUDED IN THE AR-1288RTT2-FC3 FIBERTAG TIGHTROPE II WITH INTERNALBRACE EXPERIENCED AN ISSUE DURING AN ACL PROCEDURE. WHILE DRILLING THE FEMORAL TUNNEL, THE SURGEON STARTED DRILLING INTO BONE, THEN RETRACTED THE FLIPCUTTER. APPROXIMATELY HALFWAY DOWN THE TUNNEL, THE FLIPCUTTER FRACTURED AT THE TIP OF THE SHAFT, NOT AT THE CUTTING ARM. ALL FRACTURED COMPONENTS WERE RETRIEVED FROM THE PATIENT¿S KNEE. A NEW FLIPCUTTER WAS OPENED, AND THE PROCEDURE WAS COMPLETED USING THE IMPLANTS FROM THE KIT. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 23-MAR-2026: THE CASE WAS COMPLETED USING AN AR-1204FF FLIPCUTTER III DRILL AND THE TIGHTROPES FROM THE INITIAL SYSTEM. THE CASE WAS NOT DELAYED, AS AN ADDITIONAL FLIPCUTTER WAS AVAILABLE, AND THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECES WITHOUT DIFFICULTY. BONE QUALITY WAS REPORTED AS GOOD. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816723 ↗
• MalfunctionMar 23, 2026Break

  ON 03-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1288RTT2-FC3 IMPLANT SYSTEM BROKE DURING AN ACL RECONSTRUCTION PROCEDURE. ALL FRAGMENTS WERE RECOVERED FROM THE PATIENT. THE EVENT CAUSED A BRIEF, APPROXIMATELY 2-MINUTE DELAY AND DID NOT REQUIRE ADDITIONAL ANESTHESIA. THE PATIENT WAS NOTED TO HAVE STRONG BONE QUALITY. THE PROCEDURE WAS COMPLETED USING AN AR-1204FF. NO PATIENT HARM OCCURRED. ADDITIONAL INFORMATION WAS PROVIDED ON 05-MAR-2026 WHERE THE SALES REPRESENTATIVE STATED THAT THE TIP OF THE DEVICE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663066 ↗
• MalfunctionJan 20, 2026Break

  ON (B)(6) 2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1288RTT2-FC3 FIBERTAG TIGHTROPE II EXPERIENCED AN ISSUE DURING USE. UPON PASSING THE GRAFT AND TENSIONING THE TIBIAL SIDE, THE TIGHTROPE INTERFACE BROKE DURING TENSIONING. THE FAILURE OCCURRED TWICE CONSECUTIVELY. AS A RESULT, THE TIBIAL BUTTON AND THE FEMORAL-SIDED TIGHTROPE WERE CUT OUT TO ALLOW FOR RE-SUTURING. THIS WAS DISCOVERED DURING A PEDIATRIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 08-JAN-2026: THE TWO TIGHTROPES THAT BROKE WERE THE TIBIAL-SIDED AR-1588TNT2 FIBERTAG TIGHTROPE II ABS. BECAUSE THE TIBIAL TIGHTROPE FAILED, THE ENTIRE CONSTRUCT HAD TO BE REMOVED AND THE SITE RE-PREPPED. THIS ISSUE OCCURRED WHILE THE IMPLANTS WERE IN THE PATIENT. ONCE THE TIGHTROPE SUTURES BROKE, ALL COMPONENTS WERE REMOVED AND THE SITE WAS RE-PREPARED USING PRODUCTS FROM ANOTHER MANUFACTURER, RESULTING IN A SURGICAL DELAY OF APPROXIMATELY 1.75 HOURS. ACCORDING TO THE SALES REPRESENTATIVE, NO ADDITIONAL ANESTHESIA WAS REQUIRED, AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116089 ↗
• MalfunctionJan 6, 2026Crack

  ON 17-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1288RTT2-FC3 FIBERTAG TIGHTROPE II HAD A FEMORAL BUTTON THAT APPEARED TO HAVE A CRACK AT THE END NEAR THE BLUE LEADING STITCH HOLE (SEE ATTACHED PHOTO). THIS ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED ON 22-DEC-2025 FOR WHEN FIRST IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975114 ↗
• MalfunctionNov 13, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 11/10/2025: DURING THE PROCEDURE, THE ISSUE OCCURRED INSIDE THE PATIENT. THE ENTIRE TIGHTROPE WAS REMOVED SUCCESSFULLY, AND NO COMPONENTS BROKE INSIDE THE PATIENT. TO COMPLETE THE CASE, THE GRAFT WAS COMPLETELY REMOVED FROM THE KNEE, THE CLOSED FEMORAL TIGHTROPE WAS CUT, AND THE GRAFT WAS RE-PREPPED USING AN AR-1588RTT2 FIBERTAG TIGHTROPE II. THE SURGERY WAS DELAYED BY APPROXIMATELY 30 MINUTES, AND ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23541538 ↗
• MalfunctionOct 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 09/30/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1288RTT2-FC3 IMPLANT SYSTEMS FLIPCUTTER MALFUNCTIONED. THIS OCCURRED DURING AN ACL RECONSTRUCTION ON (B)(6) 2025 WHEN THE FLIPCUTTERS DIAL WOULD NOT OPEN THE BLADE. ONCE IN POSITION THEY KEPT THE GUIDE BULLET IN PLACE AND OPENED ANOTHER FLIPCUTTER TO PROCEED. THERE WAS NO HARM ON THE PATIENT. THERE WAS ABOUT A 30-45 SECOND DELAY WHICH DID NOT REQUIRE ADDITIONAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290403 ↗
• MalfunctionOct 15, 2025Failure to Advance; Failure to Advance

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL AN ISSUE INVOLVING THE AR-1288RTT2-FC3 FIBERTAG TIGHTROPE II IMPLANT SYSTEM. DURING THE CASE, A FIBERTAG TIGHTROPE II IMPLANT SYSTEM WAS OPENED. BOTH THE FIBERTAG TIGHTROPE AND THE FIBERSNARE SUTURE FUNCTIONED AS INTENDED. HOWEVER, THE FLIPCUTTER III DRILL MALFUNCTIONED AFTER DRILLING THE FEMORAL TUNNEL. SPECIFICALLY, THE FLIPCUTTER FAILED TO EXPAND FROM ITS PRESET 3.5MM DIAMETER. DESPITE ATTEMPTS TO REMOVE RESIDUAL BONE FROM THE DISTAL TIP AND RE-EXPAND THE DEVICE, IT REMAINED LOCKED AND WOULD NOT REACH THE DESIRED DIAMETER. AS A RESULT, A SECOND IMPLANT SYSTEM HAD TO BE OPENED TO OBTAIN A REPLACEMENT FLIPCUTTER, WHICH WAS THE ONLY AVAILABLE BACKUP AT THE TIME. THE INCIDENT OCCURRED ON (B)(6) 2025 DURING A QUAD ACL PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 23279934 ↗
• MalfunctionJul 17, 2025Break; Break

  ON 06/23/2025, A SALES REPRESENTATIVE REPORTED VIA SEMS-(B)(4) THAT (2) AR-1288RTT2-FC3 IMPLANT SYSTEMS NITINOL LOOP WAS BROKEN ON THE NEEDLES. THIS WAS DISCOVERED IN A CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22533944 ↗
• MalfunctionJul 17, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT (2) AR-1288RTT2-FC3 IMPLANT SYSTEMS NITINOL LOOP WAS BROKEN ON THE NEEDLES. THIS WAS DISCOVERED IN A CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22533872 ↗
• MalfunctionMay 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED ON 05/09/2025: AN ADDITIONAL 60 MINUTES OF ANESTHESIA WERE ADMINISTERED TO THE PATIENT DURING THE PROCEDURE. NO NEGATIVE EFFECTS OR SIGNIFICANT DAMAGE WERE OBSERVED DURING OR AFTER THE SURGERY.

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

  MAUDE report 22002933 ↗
• MalfunctionMay 5, 2025Break; Break

  ON 04/23/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANT AND AN AR-1288RTT2-FC FIBERTAG TIGHTROPE II BROKE DURING THE TENSIONING PROCESS AT THE CORTICAL BUTTON. EVERYTHING WAS REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING AN AR-1288QIS-100 QUADLINK IMPLANT SYSTEM. THE CASE HAD A DELAY OF MORE THAN ONE HOUR BUT LESS THAN TWO HOURS. IT IS UNKNOWN THE AMOUNT OF ADDED ANESTHESIA ADMINISTERED TO THE PATIENT. NO ADVERSE EFFECTS WERE REPORTED ON OR AFTER THE SURGERY. THIS WAS DISCOVERED DURING A PRIMARY ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961677 ↗
• MalfunctionApr 4, 2025Break; Break

  ON 3/17/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE FLIPCUTTER III FROM AN AR-1288RTT2-FC3 FIBERTAG TIGHTROPE II FOR INTERNALBRACE TECHNIQUE WITH FLIPCUTTERIII BROKE. THE MECHANISM INSIDE THE SHAFT THAT MAKES THE BLADE FLIP, BROKE DURING RETRO DRILLING. THERE WERE NO LOOSE FRAGMENTS FROM THE FLIPCUTTER III AND THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 21772934 ↗
• MalfunctionMar 13, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-1288RTT2-FC3 IMPLANT SYSTEM, FIBERTAG® TIGHTROPE BROKE. THIS OCCURRED DURING A CASE ON (B)(6) 2025. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21596256 ↗
• MalfunctionFeb 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 1/13/2025 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE NEEDLE ATTACHED TO THE FIBERTAG TIGHTROPE FROM AN AR-1288RTT2-FC3 FIBERTAG TIGHTROPE II FOR INTERNALBRACE IMPLANT SYSTEM BROKE OFF THE SUTURE. THE SUTURE COULD NOT PASS THROUGH THE MECHANISM OF THE FIBERTAPE. THIS WAS DISCOVERED DURING A QUAD AUTOGRAFT ACL PROCEDURE ON (B)(6) 2025. THE CASE WAS COMPLETED USING ANOTHER AR-1288RTT2-FC3 FIBERTAG TIGHTROPE II FOR INTERNALBRACE IMPLANT SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 21320795 ↗
• MalfunctionFeb 5, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 1/13/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE FLIPCUTTER III FROM AN AR-1288RTT2-FC3 BENT DURING DRILLING. NOTHING BROKE IN THE PATIENT AND THE CASE WAS COMPLETED USING AN AR-12404FF FLIPCUTTER III. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 21315121 ↗
• MalfunctionOct 2, 2024Break; Break

  ON 09/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588RTT2 FIBERTAG TIGHTROPE II IMPLANT HAD THE POST THAT HOLDS THE TIGHTROBE IN THE BUTTON BREAK INSIDE THE PATIENT, AND DUE TO THE ISSUE, THE AR-1288RTT2-FC3 FIBERTAG TIGHTROPE II WAS REMOVED TO GET THE GRAFT BACK OUT OF THE PATIENT. EVERYTHING WAS REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING AN AR-1588BTB BTB TIGHTROPE AND AN AR-1288RTT2-FC3 FIBERTAG TIGHTROPE II WITH INTERNALBRACE. THERE WAS A 30-40 MINUTE DELAY DUE TO THE ISSUE. THIS WAS DISCOVERED DURING A QUAD ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20354071 ↗
• MalfunctionSep 18, 2024Break; Break

  ON 8/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE FLIPCUTTER III FROM AN AR-1288RTT2-FC3 FIBERTAG TIGHTROPE II WITH INTERNALBRACE, WITH FLIPCUTTER III DRILL, AND FIBERSNARE SUTURE KIT BROKE WHEN DRILLING IN THE FEMORAL TUNNEL. ALL BROKEN FRAGMENTS WERE REMOVED. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 9/3/2024: THE CASE WAS COMPLETED USING A SECOND FLIPCUTTER. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 20246594 ↗
• MalfunctionSep 13, 2024Break; Break

  ON 8/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE FLIPCUTTER III FROM AN AR-1288RTT2-FC3 FIBERTAG TIGHTROPE II WITH INTERNALBRACE, WITH FLIPCUTTER III DRILL, AND FIBERSNARE SUTURE KIT BROKE WHEN DRILLING IN THE FEMORAL TUNNEL. ALL BROKEN FRAGMENTS WERE REMOVED. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 9/3/2024: THE CASE WAS COMPLETED USING A REAMER. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20215139 ↗