Arthrex® AR-1288QIS-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867344747), received between Oct 24, 2022 and Oct 15, 2025 — classified as 13 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 18, 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.

• MalfunctionOct 15, 2025Break; Break

  ON 10/03/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1288QIS-90 QUADLINK IMPLANT SYSTEM EXPERIENCED AN ISSUE DURING AN ACL RECONSTRUCTION PROCEDURE USING A QUADRICEPS TENDON AUTOGRAFT ON (B)(6) 2025. THE FEMORAL TIGHTROPE BROKE WHILE TENSIONING THE GRAFT INTO THE FEMORAL TUNNEL. THE SURGEON PULLED THE GRAFT BACK OUT THROUGH THE PORTAL, AND THE TIBIAL TIGHTROPE DETACHED FROM THE FIBERTAG CONSTRUCT. ALL SUTURES WERE REMOVED FROM THE GRAFT AND RE-PREPPED WITH A NEW FIBERTAG AND FIBERTAG ABS TIGHTROPE. NO HARM WAS DONE TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 10/13/2025: AN AR-1588RTT ACL FIBERTAG TIGHTROPE IMPLANT AND AR-1588TNT ACL-FIBERTAG TIGHTROPE WERE USED TO COMPLETE THE CASE. THE SURGERY WAS DELAYED BY ABOUT 20 MINUTES. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292327 ↗
• MalfunctionJul 21, 2025Break; Break

  ON 06/28/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1288QIS-90 QUADLINK IMPLANT FLIPCUTTER BLADE BROKE OFF AND A METAL PIECE WAS LOST IN THE KNEE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. DELAY IN CASE 30 MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 22557546 ↗
• MalfunctionMar 24, 2025Break; Break

  ON 03/10/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1288QIS-90 QUADLINK IMPLANT SYSTEM HAD THE FLIPCUTTER (LOT: 24B11) IN THE KIT BROKE ON THE SHAFT WHEN RETROGRADE DRILLING THE TIBIAL TUNNEL. THE SHAFT BROKE AT THE MOST DISTAL END, BUT THE BLADE REMAINED INTACT. IT SEEMED AS IF THE FLIPCUTTER POPPED OFF. THEY USED ANOTHER FLIPCUTTER TO PUSH THE CUTTER OUT AND EXTRACT IT SUCCESSFULLY. AN X-RAY WAS ALSO PERFORMED IN THE MIDDLE OF THE CASE TO ENSURE NO METAL PIECES WERE LEFT IN THE TUNNEL OR KNEE. THE CASE WAS COMPLETED USING ANOTHER FLIPCUTTER. THERE WAS A LESS THAN 30-MINUTE DELAY IN THE CASE WITH NO ADDED ANESTHESIA ADMINISTERED TO THE PATIENT. NO ADVERSE EFFECTS WERE REPORTED. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 21677406 ↗
• MalfunctionMar 7, 2025Dull, Blunt; Dull, Blunt

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE QUAD PRO HARVESTER FROM AN AR-1288QIS-90 QUADLINK IMPLANT SYSTEM FAILED TO COMPLETELY AMPUTATE THE QUAD TENDON WHEN FULLY PRESSED. A SMALL PIECE OF TENDON REMAINED INTACT AND REQUIRED MANUAL REMOVAL BY TWISTING THE DEVICE. ADDITIONALLY, UPON UNWINDING THE SUTURE FROM THE CARD, THE SURGEON NOTICED THAT ONE WHITE TAIL HAD SLID THROUGH THE MECHANISM AND COME UNDONE. TO SALVAGE THE GRAFT PREPARATION THAT HAD ALREADY BEEN DONE, THE SURGEON UTILIZED AN AR-1588TN-21 TIGHTROPE II ABS. AFTER THIS, SURGEON WAS ABLE TO COMPLETE CASE NORMALLY. THIS WAS DISCOVERED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546387 ↗
• MalfunctionFeb 21, 2025Positioning Failure; Positioning Failure

  ON 2/7/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1288QIS-90 QUADLINK IMPLANT SYSTEM, 9MM, HAD AN ISSUE. DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025, WHEN THE PRODUCT WAS OPENED, THE TIGHTROPE CAME OUT FAULTY OUT OF THE BOX. UPON CINCHING IT DOWN INSIDE THE PATIENT, THE SUTURE WOULD NOT TENSION. THE SUTURE WAS CUT, EVERYTHING WAS REMOVED FROM THE PATIENT, AND NO PARTS OF THE IMPLANT SYSTEM BROKE INSIDE THE PATIENT. ANOTHER AR-1588RTT2 FIBERTAG TIGHTROPE II IMPLANT WITH LOT NUMBER: 15200468 WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO HARM TO THE PATIENT. ALL PARTS FROM THE IMPLANT SYSTEM WERE DISCARDED, BUT A PICTURE WAS TAKEN. THERE WAS A CASE DELAY OF 30-40 MINUTES, AND ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433345 ↗
• MalfunctionJun 11, 2024Structural Problem; Structural Problem

  ON 4/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE BLACK PLUNGER FROM AN AR-1288QIS-90 QUADLINK IMPLANT SYSTEM, WOULD NOT FIT INTO THE CLEAR-CUTTING PIECE OF THE QUADPRO. THE CLEAR PIECE WAS NOT SMALL AND DID NOT APPEAR TO BE 9MM. THIS WAS DISCOVERED WHEN THE SURGEON WAS READY TO CUT THE QUAD GRAFT DURING A QUAD ACLR PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED WITH A NEW AR-1288QIS-90 QUADLINK IMPLANT SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19508837 ↗
• MalfunctionMay 10, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  ON 05/24/2022, IT WAS REPORTED ARTHREX EMPLOYEE VIA PHONE THAT A AR-1288QIS-90 ACL TIGHTROPE KIT HAS A QUAD PRO HARVESTER THAT IS A 8MM AND SHOULD BE A 9MM. THIS WAS DISCOVERED DURING A QUAD ACL WHEN THE DEVICE WOULD NOT CUT THE GRAFT PROPERLY, THIS WAS THE RESULT OF THE DEVICE MEASURING TO SHORTING. THE CASE WAS COMPLETED USING A AR-2386-09. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286231 ↗
• MalfunctionMay 6, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON 02/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-1288QIS-90 QUADLINK IMPLANT SYSTEM HAD THE INCORRECT SIZE HARVESTER. THIS OCCURRED DURING AN ACL RECONSTRUCTION ON (B)(6) 2023 THE INITIAL CUT ON THE QUADRICEPS TENDON MEASURED A 9MM GRAFT. THE GRAFT WOULD NOT FIT INTO THE HARVESTER FROM THE KIT. A AR-2386-10 10MM HARVESTER WAS OPENED BUT WAS MUCH TOO LARGE. A AR-2386-09 9MM HARVESTER WAS OPENED AND COMPARED TO THE SIZE OF THE ORIGINAL HARVESTER AND DETERMINED TO BE LARGER. IT WAS DETERMINED THAT THE HARVESTER FROM THE AR-1288QIS-90 KIT WAS AN 8MM. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19248361 ↗
• MalfunctionOct 9, 2023Break; Material Separation; Break; Material Separation

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4)THAT AN AR-1288QIS-90 QUADLINK IMPLANT SYSTEM HAD AN ISSUE DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2023. WHEN DRILLING THE TUNNEL IN THE TIBIA, THERE WAS A STRANGE NOISE, AND THEN AFTER ASSESSING THE FLIPCUTTER, THE END OF THE MECHANISM CAME OFF COMPLETELY. A PIECE BROKE OFF INSIDE THE PATIENT AND WAS RETRIEVED. THEY HAD DRILLED THE FEMUR WITH THE SAME FLIPCUTTER WITHOUT ISSUE. A NEW FLIPCUTTER WITH AN UNKNOWN PART AND LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THERE WAS NO ADVERSE EFFECT REPORTED AND NO CASE DELAY. THE FEMUR WAS DRILLED PREVIOUSLY WITH THE SAME COMPLAINT DEVICE WITHOUT ISSUES BEFORE THE COMPLAINT DEVICE THEN BROKE IN THE TIBIA WHILE DRILLING THE TUNNEL. THE COMPLAINT DEVICE HAS BEEN DISCARDED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17897966 ↗
• MalfunctionSep 29, 2023Break; Break

  ON 9/1/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06021084 THAT AN AR-1288QIS-90 QUADLINK IMPLANT SYSTEM, 9MM 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: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17846228 ↗
• MalfunctionJul 28, 2023Break; Break

  ON 6/28/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE FIBERTAG TIGHTROPE RT FROM AN AR-1288QIS-90 QUADLINK IMPLANT SYSTEM SNAPPED AT THE SHORTENING STRAND OF THE MECHANISM DURING TENSIONING. THIS WAS DISCOVERED DURING A QUAD ACLR PROCEDURE. THE CASE WAS COMPLETED BY REMOVING THE GRAFT, PREPPING THE TIBIAL SIDE, AND USING AN AR-4030C-10 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW TO REIMPLANT THE GRAFT INSTEAD OF THE FIBERTAG TIGHTROPE RT.

  Patient problems: Insufficient Information

  MAUDE report 17418075 ↗
• MalfunctionNov 14, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A FLIPCUTTER FROM AN AR-1288QIS-90 QUADLINK IMPLANT SYSTEM, RETRACTABLE REAMER BROKE OFF AND WAS EMBEDDED IN THE BONE. THIS WAS DISCOVERED WHILE RETRO DRILLING ON THE FEMUR DURING AN ACLR PROCEDURE ON (B)(6) 2022. SURGEON USED A STRAIGHT GRASPER TO RETRIEVE ALL BROKEN FRAGMENTS. CASE WAS COMPLETED BY USING AN INDIVIDUAL AR-1204AF-100 10 MM FLIPCUTTER, AND AR-1204AF-80 8MM FLIPCUTTER II.

  Patient problems: Foreign Body In Patient

  MAUDE report 15788294 ↗
• MalfunctionOct 24, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A FLIPCUTTER III FROM AN AR-1288QIS-90 QUADLINK IMPLANT SYSTEM, CUTTING EDGE BROKE OFF EXPANDING THE ARMS OF THE SHAFT, WHILE DRILLING THE FEMORAL TUNNEL. THIS FAILURE CAUSED A DELAYED IN THE CASE TRYING TO SQUEEZE THE ARMS SMALL ENOUGH TO COME OUT THROUGH THE DRILL SLEEVE. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 15657403 ↗