Arthrex® AR-2350Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00888867301924), received between Nov 21, 2022 and Oct 29, 2025 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Break” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Use of Device Problem; Use of Device Problem

  ON 10/17/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2350 KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS AND AN AR-3642SP KNOTLESS FIBERTAK EXPERIENCED A MALFUNCTION. WHEN IMPLANTING THE TENSION-TIGHT BUTTON, FLIPPING THE BUTTON, AND ADDING TENSION, THE SUTURE MADE A CLEAN BREAK AT THE BUTTON. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413131 ↗
• MalfunctionOct 21, 2025Break; Break

  ON 10/10/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-2350 KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYSTEM EXPERIENCED AN ISSUE DURING USE. SPECIFICALLY, WHILE INSERTING THE BUTTON, THE STYLET COULD NOT BE RELEASED, AND THE TIP OF THE INSERTER, ATTACHED TO THE BUTTON, BROKE OFF. USING X-RAY IMAGING, THE IMPLANT AND THE BROKEN PIECE WERE SUCCESSFULLY REMOVED AND REPLACED WITH THE SAME PART NUMBER. THE PATIENT WAS NOT HARMED, AND THE PROCEDURE WAS ABLE TO CONTINUE AND BE COMPLETED WITHOUT FURTHER COMPLICATIONS. THIS ISSUE WAS DISCOVERED DURING A DISTAL BICEPS REPAIR PROCEDURE PERFORMED ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/13/2025. ADDITIONAL INFORMATION WAS RECEIVED ON 10/14/2025: THE PROCEDURE REQUIRED AN ADDITIONAL 20 MINUTES TO REMOVE THE FIRST IMPLANT AND A BROKEN INSERTER. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351510 ↗
• MalfunctionSep 4, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE WHITE FIBERLOOP SUTURE IN THE AR-2350 KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYSTEM SNAPPED WHILE SEATING THE BUTTON DURING USE. THE BROKEN PIECE WAS NOT RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED, AND NO ADDITIONAL DETAILS WERE PROVIDED. THIS ISSUE WAS DISCOVERED DURING AN OPEN SUBPECTORAL BICEPS TENODESIS PROCEDURE PERFORMED ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 08/19/2025: THE ISSUE OCCURRED DURING THE SEATING OF THE IMPLANT, AND NO ATTEMPT WAS MADE TO RETRIEVE THE BROKEN COMPONENT. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT AR-2350 KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYSTEM. THE CASE EXPERIENCED A TEN-MINUTE DELAY, WITH NO ADDITIONAL ANESTHESIA ADMINISTERED. NO PHOTOS WERE TAKEN, AND NO ADVERSE EFFECTS WERE REPORTED DURING OR AFTER THE SURGERY. ADDITIONAL INFORMATION RECEIVED ON 08/25/2025: THE WHITE FIBERLINK SUTURE IN THE AR-2350 KNOTLESS TENSIONTIGHT BUTTON IMPLANT SNAPPED WHILE SEATING THE BUTTON, CAUSING IT TO COME LOOSE FROM THE SUTURES AND LEAVING THE BUTTON INSIDE THE BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22962124 ↗
• MalfunctionJul 15, 2025Positioning Failure; Positioning Failure

  ON 6/18/2025, IT WAS REPORTED VIA EMAIL BY A SALES REPRESENTATIVE THAT AN AR-2350 KNOTLESS TENSION TIGHT BUTTON IMPLANT SYSTEM EXPERIENCED A FAILURE. THE TENSION TIGHT BUTTON AND SUTURE BOTH FAILED. THE # 5 FIBERLINK WAS NOT LOCKED AT THE SWEDGE, ALLOWING THE SUTURE TO SLIDE THROUGH ITSELF RATHER THAN MAINTAIN TENSION. AS THE BUTTON WAS ADVANCED PAST THE SWEDGE AREA, IT CONTINUED TO FAIL TO HOLD TENSION. A NEW BUTTON WAS OPENED TO COMPLETE THE CASE, WHILE THE FAILED BUTTON REMAINED IMPLANTED. THIS WAS DISCOVERED DURING A DISTAL BICEPS REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 06/27/2025: IT IS UNCERTAIN IF THE SUTURE, THE BUTTON, OR BOTH BROKE. IT WAS CONFIRMED THAT THE WHOLE SYSTEM FAILED. THE CASE WAS COMPLETED WITHOUT ISSUES USING ANOTHER AR-2350 KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYSTEM. THE CASE WAS DELAYED 15-20 MINUTES. IT IS UNCERTAIN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 22508070 ↗
• MalfunctionMar 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 03/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-2350 KNOTLESS TENSIONTIGHT¿ BUTTON IMPLANT SYSTEMS SUTURES SHEARED. THIS OCCURRED DURING A SHOULDER ARTHROSCOPY WITH BICEP TENODESIS ON (B)(6) 2025 WHEN THE SUTURES SHEARED, BOTH IMPLANTS REMAIN IN THE PATIENT. THE CASE WAS COMPLETED WITH A SECONDARY IMPLANT TO ENSURE FIXATION. THERE WAS NO HARM ON THE PATIENT. THIS FAILURE DID ADD ABOUT 5 MINUTES OF ADDITIONAL TIME WHERE ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651896 ↗
• MalfunctionMar 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 03/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-2350 KNOTLESS TENSIONTIGHT¿ BUTTON IMPLANT SYSTEMS SUTURES SHEARED. THIS OCCURRED DURING A SHOULDER ARTHROSCOPY WITH BICEP TENODESIS ON (B)(6) 2025 WHEN THE SUTURES SHEARED, BOTH IMPLANTS REMAIN IN THE PATIENT. THE CASE WAS COMPLETED WITH A SECONDARY IMPLANT TO ENSURE FIXATION. THERE WAS NO HARM ON THE PATIENT. THIS FAILURE DID ADD ABOUT 5 MINUTES OF ADDITIONAL TIME WHERE ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651782 ↗
• MalfunctionJan 10, 2025Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-2350 KNOTLESS TENSION TIGHT BUTTON IS BROKEN. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125082 ↗
• MalfunctionOct 24, 2024Break; Break

  ON 10/7/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2350 KNOTLESS TENSION TIGHT BUTTON IMPLANT SYSTEM SUTURE WOULD NOT SLIDE THROUGH THE BUTTON WHEN LOADING THE SUTURE THROUGH THE BUTTON. THE BUTTON ENDED UP BREAKING OFF THE INSERTER. THE CASE WAS COMPLETED USING ANOTHER AR-2350 KNOTLESS TENSION TIGHT BUTTON IMPLANT SYSTEM. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING AN OPEN BICEP PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 10/14/2024: THIS WAS DISCOVERED WHILE THE IMPLANT WAS IN THE PATIENT. ALL BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS DELAYED ABOUT TWENTY MINUTES; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20524305 ↗
• MalfunctionOct 17, 2024Break; Break

  ON 10/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2350 TENSION TIGHT BUTTON BROKE OFF THE HANDLE WHEN SHUTTLING #5 SUTURE. THE LOCKING THREADS FRACTURED OFF IN THE BUTTON. THE CASE WAS COMPLETED USING ANOTHER TENSIONTIGHT BUTTON. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO DELAY IN CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20469944 ↗
• MalfunctionAug 26, 2024Positioning Failure; Positioning Failure

  ON 08/01/2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-2350 KNOTLESS TENSION TIGHT BUTTON IMPLANT SYSTEM HAD THE BUTTON NOT CINCH DOWN AND WOULD NOT FLIP. THE CASE WAS COMPLETED USING AN AR-3770SP HYBRID KNEE FIBERTAK ANCHOR. THE CASE WAS DELAYED 30 MINUTES. IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. THIS WAS DISCOVERED DURING AN OPEN BICEPS TENODESIS PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20065392 ↗
• MalfunctionJun 9, 2024Break; Break

  ON 3/29/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE TENSIONTIGHT LOCKING BUTTON FROM AN AR-2350 KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYSTEM IS CUTTING THE NUMBER FIVE FIBERLINK SUTURES ONCE THE BUTTON IS FLIPPED AND TENSIONED. THIS WAS DISCOVERED DURING A PROXIMAL BICEP REPAIR PROCEDURE ON (B)(6) 2023. THE BUTTON WAS LEFT INSIDE THE PATIENT, AND THE SUTURES WERE REMOVED. ADDITIONAL INFORMATION RECEIVED ON 12/11/2023: THE BUTTON WAS NOT IMPLANTED, AND THE CASE WAS COMPLETED USING AN AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEM. OTHER THAN THE SUTURES, NOTHING BROKE INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19495288 ↗
• MalfunctionMay 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2350 TENSION TIGHT BUTTON PULLED OUT OF THE BONE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19381546 ↗
• InjuryMay 20, 2024Positioning Failure; Positioning Failure

  ON 11/23/2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA E-MAIL THAT A AR-2350 IMPLANT SYSTEM SUTURE PULLED THROUGH. THIS OCCURRED DURING A SUBPECTORAL BICEPS TENODESIS, WHEN THE SURGEON BEGAN USING THE TENSIONTIGHT BUTTON IMPLANT SYSTEM HE USED THE LOOP AND TACK STITCH METHOD AS DEMONSTRATED THROUGH THE TECHNIQUE GUIDE AFTER COMPLETING THE PASS OF THE #5 FIBERLINK THROUGH THE BICEP TISSUE THE SURGEON PULLED THENSION TO REMOVE ALL SLACK IN THE SUTURE AND THE SUTURE PULLED THROUGH CAUSING HIM TO LOSE THE BICEP TENDON AS IT RETRACTED DOWN INTO THE ARM. THE SURGEON WAS UNABLE TO USE THE SYSTEM TO COMPLETE THE CASE, HE ENDED UP UTILIZING ANOTHER TENODESIS METHOD AND WAS ABLE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 11/23/2021 : THE PROCEDURE BEING PERFORMED WAS A SUBPECTORAL BICEPS TENODESIS. THERE WAS NO INSTRUMENT USED TO PREPARE THE BONE SOCKET AS THE SUTURE PULLED THROUGH THE TENDON PRIOR TO THAT STEP OF THE PROCEDURE. THE SUTURE WAS FULLY RETRIEVED FROM THE PATIENT. THE BONE QUALITY OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19350371 ↗
• MalfunctionMay 3, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2350 TENSION TIGHT BUTTON THREADS ON THE INSERTER ARE STRIPPED AND ARE CAUSING THE IMPLANT TO NOT SEAT. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19238208 ↗
• MalfunctionApr 12, 2024Defective Device; Defective Device

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-2350 KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYSTEM MALFUNCTIONED. THIS OCCURRED DURING A OPEN SUBPECTORAL BICEPS TENODESIS ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 19099008 ↗
• MalfunctionFeb 16, 2024Failure to Advance; Failure to Advance

  ON 01/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-2350 KNOTLESS TENSIONTIGHT¿ BUTTON IMPLANT SYSTEMS FIBERLINK WOULD NOT SLIDE APPROPRIATELY THROUGH THE TRAP DOOR. THIS OCCURRED DURING A CASE WHEN PERFORMING THE TENSION-TIGHT BUTTON BICEPS BUTTON TECHNIQUE, THE FIVE FIBERLINK WOULD NOT SLIDE APPROPRIATELY THROUGH THE TRAP DOOR. THE BUTTON WAS RELEASED FROM THE INSERTER IN THE HUMERAL CANAL AND AS LIGHT TENSION WAS APPLIED TO THE 5 FIBERLINK, IT RIPPED. THE METAL BUTTON WAS LEFT INSIDE THE HUMERAL CANAL AND COULD NOT BE REMOVED. THE SURGEON THEN USED A BIRMINGHAM AR-1662S-1 BICEPS KIT TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18720057 ↗
• MalfunctionJan 5, 2024Break; Break

  ON 2/22/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE INSERTER FROM AN AR-2350 KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYSTEM BROKE OFF IN THE BUTTON. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 2/22/2023: THE INNER THREADED INSERTER BROKE OFF WHILE IT WAS BEING IMPLANTED. IT WAS CONTAINED WITHIN THE CANNULATED INSERTER SHAFT, SO NO FRAGMENTS WERE IN THE PATIENT. THIS WAS DISCOVERED DURING AN RCR PROCEDURE AND COMPLETED WITH ANOTHER AR-2350 KNOTLESS TENSION TIGHT BUTTON IMPLANT SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 18455857 ↗
• MalfunctionMay 1, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2350 KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYSTEM FAILED. THIS OCCURRED DURING A SUBPECTORAL BICEPS TENODESIS CASE ON (B)(6) 2023 WHEN THEY WERE HAVING TROUBLE GETTING THE BUTTON IN, AFTER THE 2ND OR 3RD TRY IT WAS PULLED OUT AND APPEARED THAT A PIECE OF THE METAL WAS SHIFTED AND WAS STICKING OUT, MAKING IT UNABLE TO FIT INTO THE PREPARED SOCKET. THE INSERTER BROKE WHILE IN THE PATIENT AND ALL FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED BY GETTING RID OF THE FAULTY BUTTON THEY OPENED ANOTHER AR-2350 FROM ANOTHER LOT AND THAT ONE WORKED ACCORDINGLY. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16843708 ↗
• MalfunctionNov 21, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-2350 KNOTLESS TENSION TIGHT BUTTON IMPLANT SYSTEM MALFUNCTIONED. THIS OCCURRED DURING A OPEN SUB-PECTORAL BICEPS TENODESIS ON (B)(6) 2022 WHEN THE BLACK FLAG THAT FEEDS THE SUTURE MECHANISM THROUGH THE BUTTON WOULD NOT SHUTTLE THE SUTURE THROUGH THE BUTTON, AND AS A RESULT IT BROKE. ANOTHER AR-2350 WAS OPENED AND THE CASE WAS COMPLETED. THERE WAS NO FRAGMENT PRODUCED. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834937 ↗