Arthrex® AR-1288QIS-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00888867344754), received between Sep 6, 2022 and Oct 15, 2025 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Break” (13 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.

• MalfunctionOct 15, 2025Break; Break

  ON 10/02/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE FLIPCUTTER III COMPONENT FROM THE AR-1288QIS-100 QUADLINK IMPLANT SYSTEM EXPERIENCED BREAKAGE WHILE REAMING THE TIBIAL TUNNEL. THE INNER ROD OF THE FLIPCUTTER SEPARATED FROM THE OUTER SHEATH. THE INNER SHEATH WAS REMOVED WITHOUT INCIDENT BY CLOSING THE FLIPCUTTER WITH A LOCKING GRASPER. THE CASE WAS COMPLETED SUCCESSFULLY, AND NO FURTHER DETAILS WERE PROVIDED. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/06/2025. ADDITIONAL INFORMATION WAS RECEIVED ON 10/7/2025: DURING THE PROCEDURE, THE INTERNAL SLEEVE CONTAINING THE FLIPCUTTER BLADE DETACHED FROM THE EXTERNAL SLEEVE. HOWEVER, THE INTERNAL SLEEVE WITH THE BLADE WAS SUCCESSFULLY REMOVED WITHOUT INCIDENT. THE PRODUCT INVOLVED WAS AR-1204FF FLIPCUTTER III. THE CASE WAS NOT SIGNIFICANTLY DELAYED, AS THE FLIPCUTTER BLADE WAS CLOSED USING A GRASPER AND RETRACTED THROUGH THE ACL TUNNEL WITHIN MOMENTS. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE EFFECTS HAVE BEEN REPORTED TO DATE. NO FRAGMENTS WERE RETAINED INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292650 ↗
• MalfunctionMay 30, 2025Break; Break

  ADDITIONAL INFORMATION WAS PROVIDED ON 05/28/2025, WHERE THE SALES REPRESENTATIVE STATED THE HARVESTER DID NOT BREAK AS IT WAS SIMPLY DULL AND WOULD NOT CUT. THE FIBERTAG SUTURE BROKE WHEN THE SURGEON WAS PREPARING THE GRAFT AND PULLING ON IT. THE PATIENT'S BONE QUALITY WAS GOOD. NO INSTRUMENT WAS USED TO PREPARE THE BONE SOCKET. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THEY OPENED ANOTHER QUADLINK KIT TO COMPLETE THE PROCEDURE. A SMALL DELAY OCCURRED, NO MORE THAN 2 MINUTES. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 22117629 ↗
• MalfunctionMay 30, 2025Break; Break

  ON 05/07/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1288QIS-100 QUADLINK IMPLANT SYSTEM MALFUNCTIONED DURING USE. THE FIBERTAG TIGHTROPE ABS IMPLANT BROKE WHEN THE SURGEON WAS PREPARING THE GRAFT, AND THE QUADPRO HARVESTER WAS DULL AND COULD NOT CUT THE QUAD TENDON FOR HARVEST. THE CASE WAS COMPLETED, AND NO PATIENT HARM WAS REPORTED. THIS WAS DISCOVERED DURING AN AUTOGRAFT QUADRICEPS ACL RECONSTRUCTION PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 05/29/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115917 ↗
• MalfunctionMar 17, 2025Failure to Advance; Failure to Advance

  ON 2/28/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1288QIS-100 QUADLINK IMPLANT SYSTEM HAD AN ISSUE DURING A QUADRICEPS ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025. WHEN THE SURGEON WAS CINCHING THE SUTURES, ONE SIDE PREMATURELY TENSIONED DOWN AND DID NOT ALLOW THE IMPLANT TO TENSION APPROPRIATELY. 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-1588TNT ACL-FIBERTAG-TIGHTROPE ABS-IMPLANT WITH AN UNKNOWN LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A CASE DELAY OF UNDER 15 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 21619555 ↗
• MalfunctionJan 13, 2025Break; Break

  ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE BLADE OF THE FLIPCUTTER III FROM AN AR-1288QIS-100 QUADLINK IMPLANT SYSTEM BROKE OFF DURING DRILLING. DUE TO THIS, THE SURGEON HAD TO DRILL A LARGER TUNNEL, LEADING TO HAVING TO USE BUTTON EXTENDERS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6)2024. ADDITIONAL INFORMATION RECEIVED ON 12/26/2024: THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE. ALL THE BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED BY COMPLETING THE REAMING PROCESS WITH ANOTHER REAMER, WHICH RESULTED IN THE USE OF A BUTTON EXTENDER. THE CASE WAS DELAYED BETWEEN TEN TO TWENTY MINUTES; HOWEVER, THE SALES REPRESENTATIVE DOES NOT KNOW IF ADDITIONAL ANESTHESIA WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 21138362 ↗
• MalfunctionJan 13, 2025Break; Break

  ON 12/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE BLADE OF THE FLIPCUTTER III FROM AN AR-1288QIS-100 QUADLINK IMPLANT SYSTEM BROKE OFF DURING DRILLING. DUE TO THIS, THE SURGEON HAD TO DRILL A LARGER TUNNEL, LEADING TO HAVING TO USE BUTTON EXTENDERS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 12/26/2024: THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE. ALL THE BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED BY COMPLETING THE REAMING PROCESS WITH ANOTHER REAMER. THE CASE WAS DELAYED BETWEEN TEN TO TWENTY MINUTES; HOWEVER, THE SALES REPRESENTATIVE DOES NOT KNOW IF ADDITIONAL ANESTHESIA WAS USED.

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

  MAUDE report 21138322 ↗
• MalfunctionJan 13, 2025Break; Break

  ON 12/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE BLADE OF THE FLIPCUTTER III FROM AN AR-1288QIS-100 QUADLINK IMPLANT SYSTEM BROKE OFF DURING DRILLING. DUE TO THIS, THE SURGEON HAD TO DRILL A LARGER TUNNEL, LEADING TO HAVING TO USE BUTTON EXTENDERS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 12/26/2024: THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE. ALL THE BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED BY USING A NEW FLIPCUTTER III WITH A 17 MM BUTTON. THE CASE WAS DELAYED ABOUT SEVENTEEN MINUTES; HOWEVER, THE SALES REPRESENTATIVE DOES NOT KNOW IF ADDITIONAL ANESTHESIA WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 21138240 ↗
• MalfunctionSep 25, 2024Break; Break

  ON 09/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1288QIS-100 QUADLINK IMPLANT SYSTEM BROKE. THIS OCCURRED DURING AN ACL PRIMARY RECONSTRUCTION WHEN THE FLIPCUTTER III IN THE 10MM QUADLINK IMPLANT SYSTEM BROKE WHILE REAMING THE TIBIAL TUNNEL. THE OUTER SHAFT THAT ATTACHES TO THE FLIPCUTTER III DIAL HOUSING BROKE LOOSE FROM THE PLASTIC RESULTING IN THE INNER MECHANICAL MECHANISM BREAKING AS WELL. AT THAT POINT, THEY HAD TO USE THE GRASPERS TO FORCE THE FLIP CUTTER BLADE TO CLOSE SO THAT THEY COULD REMOVE IT FROM THE JOINT. THIS ADDED SUBSTANTIAL TIME TO THE CASE.

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

  MAUDE report 20301032 ↗
• MalfunctionJul 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 07/02/2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1288QIS-100 QUADLINK IMPLANT SYSTEM HAD BOTH TIGHTROPE NEEDLES POPPED OFF PREMATURELY. TWO NEW TIGHT ROBE NEEDLES WERE USED FROM OPENING ANOTHER AR-1288QIS-100 QUADLINK IMPLANT SYSTEM WITH NO ISSUES TO COMPLETE THE CASE. THERE WAS NO DELAY IN THE PROCEDURE. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819549 ↗
• MalfunctionJul 24, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 07/1/2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1288QIS-100 QUADLINK IMPLANT SYSTEM HARVESTER WAS LOCKED UP WITHIN AND WOULD NOT CUT THE GRAFT DURING GRAFT HARVEST ON THE PATIENT. THE CASE WAS COMPLETED BY CUTTING THE GRAFT OUT BY HAND, AND THE CASE CONTINUED AS PLANNED. THERE WAS A ONE-MINUTE DELAY IN THE CASE. NOTHING BROKE IN THE PATIENT. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819381 ↗
• InjuryJul 24, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 6/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE PLUNGER AND HARVESTER FROM AN AR-1288QIS-100 QUADLINK IMPLANT SYSTEM GOT STUCK WHEN THE GRAFT WAS HARVESTED AND COULD NOT BE PULLED APART. THE SURGEON HAD TO USE PLIERS TO REMOVE THE PLUNGER. UPON SEPARATING THE DEVICES, IT WAS NOTICED THAT THE GRAFT WAS NO LONGER USABLE. THE SURGEON INTENDED TO HARVEST A QUAD AUTOGRAFT HOWEVER, THE SURGEON HAD TO BAIL TO A HAMSTRING GRAFT. THE APPROPRIATE KIT WAS OPENED TO CREATE AN ADDITIONAL INCISION AND HARVEST A HAMSTRING GRAFT FROM THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY WITH THE HAMSTRING GRAFT. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19817730 ↗
• MalfunctionJun 13, 2024Defective Component; Defective Component

  ON 04/03/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1288QIS-100 QUADLINK IMPLANT SYSTEM FAILED, THEY WERE UNABLE TO DETECT THE ROOT CAUSE FAILURE. THIS OCCURRED DURING A CASE, THE CASE WAS COMPLETED USING ANOTHER AR-1288QIS-100. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533401 ↗
• MalfunctionJun 10, 2024Mechanical Jam; Mechanical Jam

  ON 3/8/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT FLIPCUTTER III FROM AN AR-1288QIS-100 QUADLINK IMPLANT SYSTEM WOULD NOT CLOSE BACK TO ITS 3.5 MM POSITION AFTER DRILLING THE FEMORAL TUNNEL TO A 9 MM HOLE. SURGEON HAD TO USE AN ARTHROSCOPY GRASPER TO SQUEEZE THE BLADE SHUT. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19505462 ↗
• MalfunctionMay 27, 2024Material Deformation; Material Deformation

  ON 10/3/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE QUADPRO FROM AN AR-1288QIS-100 QUADLINK IMPLANT SYSTEM, THINNED OUT THE GRAFT OUT PROXIMALLY. WHAT STARTED AS A 10MM GRAFT, ENDED AS AN 8MM ON THE PROXIMAL END. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19402327 ↗
• MalfunctionMay 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED ON 05/23/2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-1288QIS-100 QUADLINK IMPLANT NEEDLE PULLED OUT. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353479 ↗
• MalfunctionMay 10, 2024Dull, Blunt; Dull, Blunt

  ON 4/20/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1288QIS-100 IMPLANT KIT HAD A PLUNGER THAT WAS NOT SHARP AND SURGEON HAD PROBLEMS CUTTING HE GRAFT OUT, WHICH RESULTED IN A HALF LENGTH INADEQUATE GRAFT. SURGEON USED A BTB GRAFT AND A DIFFERENT SYSTEM TO COMPLETE THE CASE. THIS CAUSED A DELAYED IN THE SURGERY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19287119 ↗
• MalfunctionJan 22, 2024Break; Break

  ON 12/20/2023, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. AN UNKNOWN SOURCE REPORTED THAT THE TIP OF A DEVICE FROM AN AR-1288QIS-100 QUADLINK IMPLANT SYSTEM, 10MM BROKE INSIDE THE PATIENT. EVERYTHING WAS REMOVED FROM INSIDE THE PATIENT WITH NO ADVERSE OUTCOME TO THE PATIENT. THIS WAS DISCOVERED DURING A LEFT KNEE ARTHROSCOPY AND ACLR WITH QUADRICEPS TENDON AUTOGRAFT PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18551890 ↗
• MalfunctionJan 5, 2024Break; Break

  ON 12/8/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT THE FLIPCUTTER II FROM AN AR-1288QIS-100 QUADLINK IMPLANT SYSTEM TIP BROKE. WHEN THE SURGEON ATTEMPTED TO FLIP THE BLADE AND REAM A TUNNEL, THE TIP BROKE. THE FRAGMENTS WERE RETRIEVED AND AN AR-1204FF FLIPCUTTER III WAS OPENED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2023.

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

  MAUDE report 18453272 ↗
• MalfunctionDec 15, 2023Break; Break

  ON 11/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4), THAT AN AR-1288QIS-100 QUADLINK IMPLANT SYSTEMS TIP OF THE FLIPCUTTER BROKE OFF. THIS OCCURRED DURING A CASE, WHERE A NEW DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 18340889 ↗
• MalfunctionSep 29, 2023Break; Break

  ON 9/1/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06021084 THAT AN AR-1288QIS-100 QUADLINK IMPLANT SYSTEM, 10MM 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 17845047 ↗
• MalfunctionJul 10, 2023Break; Break

  ON 6/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE FLIPCUTTER III FROM AN AR-1288QIS-100 QUADLINK IMPLANT SYSTEM BROKE WHILE RETRO DRILLING THE TIBIAL TUNNEL. THE FLIPCUTTER III DID NOT COMPLETE THE BONE SOCKET AND CLOSED BACK TO A 3.5MM IN DIAMETER. THE SURGEON OPENED A NEW AR-1204FF FLIPCUTTER III TO CONTINUE DRILLING, AND THIS ONE WOBBLED WHILE ON POWER, AFTER ATTEMPTING TO CHUCK IT MULTIPLE TIMES. THIS WAS DISCOVERED DURING AN ALL-INSIDE ACLR PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17287522 ↗
• MalfunctionSep 6, 2022Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1288QIS-100 QUADLINK SYSTEMS FLIPCUTTER 3 BROKE OFF WHILE THE SURGEON WAS DRILLING. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE JOINT SPACE.

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

  MAUDE report 15362671 ↗