Arthrex® AR-2290Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00888867026698), received between Dec 6, 2017 and Dec 1, 2025 — classified as 6 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Positioning Failure; Positioning Failure

  ON 11/3/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THREE AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEMS EXPERIENCED DEPLOYMENT ISSUES. SPECIFICALLY, THE BUTTON ON THE INSERTER WOULD NOT REMAIN ATTACHED TO THE SILVER THREADED PORTION. ONE BUTTON DETACHED AND FELL TO THE FLOOR, WHILE TWO OTHERS FAILED TO DEPLOY CORRECTLY. ONE WAS EVENTUALLY FORCED INTO PLACE. THESE ISSUES OCCURRED DURING A BICEPS TENODESIS PROCEDURE PERFORMED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679795 ↗
• MalfunctionDec 1, 2025Positioning Failure; Positioning Failure

  ON 11/3/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THREE AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEMS EXPERIENCED DEPLOYMENT ISSUES. SPECIFICALLY, THE BUTTON ON THE INSERTER WOULD NOT REMAIN ATTACHED TO THE SILVER THREADED PORTION. ONE BUTTON DETACHED AND FELL TO THE FLOOR, WHILE TWO OTHERS FAILED TO DEPLOY CORRECTLY. ONE WAS EVENTUALLY FORCED INTO PLACE. THESE ISSUES OCCURRED DURING A BICEPS TENODESIS PROCEDURE PERFORMED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679791 ↗
• MalfunctionDec 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/3/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THREE AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEMS EXPERIENCED DEPLOYMENT ISSUES. SPECIFICALLY, THE BUTTON ON THE INSERTER WOULD NOT REMAIN ATTACHED TO THE SILVER THREADED PORTION. ONE BUTTON DETACHED AND FELL TO THE FLOOR, WHILE TWO OTHERS FAILED TO DEPLOY CORRECTLY. ONE WAS EVENTUALLY FORCED INTO PLACE. THESE ISSUES OCCURRED DURING A BICEPS TENODESIS PROCEDURE PERFORMED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679790 ↗
• MalfunctionOct 30, 2025Break; Break

  ON 10/22/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT DURING A REPAIR OF THE ACHILLES TENDON AND TRANSFER OF ANOTHER TENDON PROCEDURE, INVOLVING THE AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEM, THE INTERFACE BETWEEN THE ROD AND IMPLANT FAILED. THE IMPLANT BROKE UPON INSERTION WITH MINIMAL PRESSURE. THERE WAS NO HARM TO THE PATIENT. THE BROKEN PIECE WAS REMOVED, AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427019 ↗
• MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 10/15/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEM EXPERIENCED AN ISSUE DURING USE. WHEN ATTEMPTING TO DEPLOY THE SUB-PEC BUTTON, THE BUTTON RELEASED PREMATURELY. ATTEMPTS TO RE-THREAD THE BUTTON ONTO THE INSERTER WERE UNSUCCESSFUL, AS THE THREADS WOULD NOT HOLD THE BUTTON IN PLACE DESPITE MULTIPLE ATTEMPTS. THE IMPLANT WAS ABANDONED, AND A NEW IMPLANT KIT WAS OPENED TO USE A NEW BUTTON AND INSERTER. AFTER THE PROCEDURE, ADDITIONAL ATTEMPTS WERE MADE WITHOUT SUCCESS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 10/20/2025: DURING A SHOULDER ARTHROSCOPY WITH SUB-PECTORAL TENODESIS PERFORMED ON (B)(6) 2025, THE BUTTON PREMATURELY DETACHED WHILE BEING INSERTED INTO THE PATIENT. THE BUTTON WAS REMOVED, AND AN ATTEMPT WAS MADE TO REATTACH IT TO THE INSERTER, WHICH WAS UNSUCCESSFUL. AS A RESULT, THE ANCHOR WAS REMOVED AND NOT REINSERTED. NO PIECES BROKE OFF INSIDE THE PATIENT DUE TO THE ISSUE, AND THERE WERE NO RETAINED FRAGMENTS. THE SURGERY EXPERIENCED A BRIEF DELAY OF APPROXIMATELY 8 MINUTES DUE TO EFFORTS TO RE-THREAD THE BUTTON. THE SURGEON ULTIMATELY DISCONTINUED USE OF THE INIT

  Patient problems: Insufficient Information

  MAUDE report 23406316 ↗
• InjuryApr 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT-REPORTED VIA EMAIL TO BE EXPERIENCING ADVERSE EFFECTS. THE PATIENT UNDERWENT BICEP SURGERY ON (B)(6) 2025, DURING WHICH A 3.2 MM FIBERLOOP BUTTON IMPLANT SYSTEM WAS USED. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 4/9/2025: THE PATIENT UNDERWENT SURGERY ON THE RIGHT HAND. EIGHT DAYS POSTOPERATIVELY, THE PATIENT EXPERIENCED SYMPTOMS INCLUDING ITCHINESS, SWELLING, REDNESS, AND PAIN UPON MOVEMENT, AFFECTING BOTH PALMS. THESE SYMPTOMS DISRUPTED THE PATIENT'S SLEEP. TO MANAGE THE SYMPTOMS, THE PATIENT TOOK BENADRYL AND ZYRTEC. ADDITIONALLY, THE PATIENT HAS UNDERGONE AN ALLERGY TEST, AND THE RESULTS ARE PENDING.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21859445 ↗
• MalfunctionApr 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 3/17/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-2290 IMPLANT SYSTEM, PROXIMAL TENODESIS, HAD AN ISSUE DURING A SHOULDER BICEPS TENODESIS PROCEDURE ON (B)(6) 2025. WHEN THE SURGEON WAS REMOVING THE INSERTER FROM THE PATIENT AFTER INSERTION, THE IMPLANT CAME OUT ON THE SUTURE. IT HAD FALLEN OFF THE INSERTER, AND THE SURGEON WAS UNABLE TO GET IT BACK ON THE INSERTER. THE IMPLANT BUTTON AND SUTURES WERE REMOVED FROM THE PATIENT IN ONE PIECE. THE COMPLAINT DEVICE WAS DISCARDED, AND NO PICTURES WERE TAKEN. ANOTHER AR-2290 IMPLANT SYSTEM, PROXIMAL TENODESIS, WITH THE SAME LOT NUMBER, WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO HARM. THERE WAS A SLIGHT CASE DELAY OF UNDER 15 MINUTES, AND IT COULD NOT BE CONFIRMED IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21772300 ↗
• InjuryMar 11, 2025Break; Break

  ON (B)(6)2025, A PATIENT REPORTED VIA PHONE THAT AN AR-2290 IMPLANT SYSTEM, PROXIMAL TENODESIS HAD AN ISSUE DURING AN ARTHROSCOPIC TENODESIS PROCEDURE WITH LABRAL REPAIR IN THE LEFT SHOULDER ON (B)(6)2024 AFTER A SHOULDER DISLOCATION. WHEN THE SURGEON TRIED TO PUT IN THE SUTURE, THE LABRUM BROKE EVEN MORE SO THAT THEY COULD NOT FIX IT. THE BICEPS TENODESIS PART OF THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS NOT EXPERIENCING ANY ISSUES. THE PATIENT WAS INQUIRING ABOUT THE MATERIAL COMPOSITION OF THE IMPLANT SYSTEM FOR AN UPCOMING SCHEDULED MRI. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: Failure of Implant

  MAUDE report 21573412 ↗
• MalfunctionMar 6, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE BUTTON FROM AN AR-2290 PROXIMAL TENODESIS WOULD NOT STAY ON THE INSERTER. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED ON 2/17/2025.

  Patient problems: Insufficient Information

  MAUDE report 21536040 ↗
• MalfunctionFeb 24, 2025Break; Break

  ON 02/10/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEM HAD AN ISSUE WHEN INSERTING THE BUTTON. THE PIECE HOLDING IT ON THE BUTTON INSERTER BROKE OFF IN THE BUTTON, AND THEY COULD NOT GET IT IN THERE. THERE WAS NO IMPACT ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445376 ↗
• MalfunctionNov 20, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE TIP OF THE DRILL PIN FROM AN AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEM BROKE IN THE PATIENT. THE CASE WAS COMPLETED USING A SECOND AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEM. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736161 ↗
• MalfunctionOct 29, 2024Break; Use of Device Problem; Break; Use of Device Problem

  UPDATE AVOE 05-DEC-2024. IT WAS CONFIRMED THAT THE BUTTON DID NOT BREAK AND REMAINED IN THE PATIENT. THERE WAS NO FRAGMENT LOOSE IN THE PATIENT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20557455 ↗
• MalfunctionOct 23, 2024Break; Break

  ON 10/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE BUTTON FROM AN AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEM BROKE OFF THE INSERTER SHAFT BEFORE IT WAS INSERTED INTO THE CANAL. THE BROKEN PIECE OF BUTTON INSERTER WAS STUCK IN BUTTON, SO IT COULD NOT BE IMPLANTED. THIS WAS DISCOVERED DURING A PROXIMAL BICEPS TENODESIS PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514805 ↗
• MalfunctionOct 10, 2024Break; Break

  ON 10/02/2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA PHONE THAT AN AR-2290 IMPLANT SYSTEMS BUTTON INSERTER BROKE. THIS OCCURRED DURING A PROXIMAL BICEPS TENODESIS ON (B)(6) 2024 WHEN THE BUTTON INSERTER BROKE AS THEY WERE GOING TO INSERT IT INTO THE PATIENT. THE CASE CONTINUED USING A TENSION TIGHT BUTTON TO COMPLETE THE CASE. THERE WAS NO DELAY.

  Patient problems: Insufficient Information

  MAUDE report 20417660 ↗
• MalfunctionSep 11, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2290 PROXIMAL TENODESIS BUTTON BROKE OFF THE INSERTER HANDLE BEFORE INSERTION. LEAVING PART OF THE THREADS INSIDE THE BUTTON AND THE INNER SHAFT BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20192118 ↗
• MalfunctionSep 11, 2024Break; Break

  ON (B)(6) 2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEM BROKE DURING USE. WHEN RELEASING THE BUTTON, THE SURGEON UNSCREWED THE STYLET, NOTICED IT WAS TIGHT, AND POPPED. THE STYLET BROKE BUT STAYED INSIDE THE BUTTON AND CAUSED THE THREADS TO BREAK OFF. THE BUTTON WAS UNABLE TO BE INSERTED AFTER THIS ISSUE. EVERYTHING WAS REMOVED FROM THE PATIENT, AND A NEW AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEM WAS OPENED WITHOUT DELAY. THIS WAS DISCOVERED DURING A PROXIMAL BICEPS TENODESIS PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 8/22/2024 VIA EMAIL WITH PHOTO ATTACHMENT: PER THE REP ON PHOTO ATTACHMENT, "AS YOU CAN SEE IN THE PHOTO, THE THREADS OF THE INSERTER ARE STILL WITHIN THE BUTTON. THE IMPLANT WAS NOT MANIPULATED WHEN TAKEN OUT OF THE PACKAGE AND WENT STRAIGHT INTO USE. THE PHYSICIAN EXPRESSED IT FELT VERY HARD TO UNSCREW THE INSERTER AND THEN POPPED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192092 ↗
• MalfunctionJun 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROXIMAL BICEPS TENODESIS SURGERY THE BUTTON OF THE DEVICE BROKE OFF FROM THE INSERTER DURING INSERTION OF THE DEVICE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19638554 ↗
• MalfunctionJun 6, 2024Break; Break

  ON 2/24/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEM BUTTON BROKE AFTER THE SUTURES WERE PASSED AND TENSION WAS APPLIED. INSERTER THREADS COVERED THE BUTTONHOLE AND SNAPPED OFF THE EYELET. THIS WAS DISCOVERED DURING A PROXIMAL BICEPS TENODESIS PROCEDURE ON (B)(6) 2023. NOTHING BROKE OFF INSIDE THE PATIENT, AS THIS OCCURRED OUTSIDE WHILE LOADING AND TENSIONING THE SUTURES FOR IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19479915 ↗
• MalfunctionJun 6, 2024Fitting Problem; Fitting Problem

  ON 12/08/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-2290 IMPLANT WOULD NOT FIT THROUGH THE SECOND HOLE. IT WAS REPLACED AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. TO DATE, THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477449 ↗
• MalfunctionJun 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 5/11/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEM BUTTON FELL OFF THE INSERTER AT SOME POINT BETWEEN OPENING PACKAGE AND BEING HANDED TO THE SURGEON AND IT CANNOT BE FOUND. X-RAY WERE TAKEN AND IT HAS BEEN CONFIRMED THAT HE BUTTON IS NOT INSIDE THE PATIENT. SURGEON OPENED ANOTHER KIT AND WAS ABLE TO COMPLETE THE CASE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A PROXIMAL BICEP TENODESIS PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447410 ↗
• MalfunctionJun 3, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE BUTTON WOULD NOT DEPLOY. THEY USED A PEEK IMPLANT TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446080 ↗
• MalfunctionMay 7, 2024Break; Break

  ON 3/15/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWICE, THE FIBERLOOP SUTURE OF AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEM BROKE DURING INSERTION AND PULLING THE TENDON. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 3/17/2022: THIS WAS DISCOVERED DURING AN OPEN PROXIMAL BICEP REPAIR AND WAS COMPLETED USING ANOTHER AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEM FROM THE SAME LOT NUMBER.

  Patient problems: Insufficient Information

  MAUDE report 19257620 ↗
• MalfunctionMay 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BICEPS BUTTON WAS NOT FULLY INTACT ON THE METAL INSERTER. WHEN PASSING THE SUTURES THROUGH THE BUTTON, THE BUTTON FELL OFF AND IT WAS DISCOVERED THAT IT WAS NOT ORIGINALLY THREADED ON THE METAL INSERTER. THE REP CONFIRMED THE DEVICE DID NOT BREAK IN THE PATIENT. A NEW KIT WAS OPENED AND USED IN THE PROCEDURE. SEE ATTACHED IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257545 ↗
• MalfunctionMay 3, 2024Break; Break

  ON 12/14/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE BUTTON FROM AN AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEM, WAS NOT CONNECTED TO THE INSERTER AND APPEARED BROKEN. SURGEON WAS ABLE TO CONNECT IT AGAIN BUT DURING INSERTION IT WOULD NOT SEAT. CASE WAS COMPLETED BY OPENING AN INDIVIDUAL BUTTON, PART NUMBER IS UNKNOWN. THIS WAS DISCOVERED DURING A RCR AND BICEP REPAIR ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19240605 ↗
• MalfunctionFeb 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 2/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE BUTTON FROM AN AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEM FELL OFF THE INSERTER DURING IMPLANTATION. THE BUTTON WAS ATTACHED BY THE SUTURES, AND IT DID NOT BECOME LOOSE INSIDE THE PATIENT. WHEN THE BUTTON DETACHED FROM THE INSERTER, IT WAS NOT IN THE BONE, BUT IT WAS WHILE IN THE JOINT SPACE. THIS WAS DISCOVERED DURING A BICEPS TENODESIS PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING AN AR-2291 PROXIMAL TENODESIS BUTTON.

  Patient problems: Insufficient Information

  MAUDE report 18810803 ↗