Arthrex® AR-2291Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867026704), received between Feb 1, 2021 and Dec 9, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Use of Device Problem; Use of Device Problem

  ON 11/21/2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-2291 PROXIMAL TENODESIS BUTTON EXPERIENCED AN ISSUE DURING USE. THE PLASTIC PROTECTIVE PIECE THAT NORMALLY SITS OVER THE TOP OF THE BUTTON WAS NOT ATTACHED TO THE BUTTON AND WAS FOUND LOOSE IN THE PACKAGING. AS A RESULT, THE PEG THAT SECURES THE BUTTON WAS WEAKENED, AND THE BUTTON SNAPPED WHEN THE USER ATTEMPTED TO THREAD THE FIBERWIRE THROUGH. THIS WAS DISCOVERED DURING A BICEPS TENODESIS PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 11/26/2025: DURING A BICEPS TENODESIS PROCEDURE, TWO AR-2291 PROXIMAL TENODESIS BUTTONS FROM THE SAME LOT WERE OPENED. UPON OPENING THE PACKAGING, STAFF OBSERVED THAT THE PLASTIC PROTECTIVE PIECES WERE NOT ATTACHED TO THE BUTTONS AND WERE LOOSE WITHIN THE PACKAGING. AFTER THREADING FIBERWIRE THROUGH THE FIRST BUTTON, IT SNAPPED OFF IMMEDIATELY. THE PROCEDURE WAS COMPLETED USING A SECOND AR-2291 PROXIMAL TENODESIS BUTTON, WHICH ALSO LACKED THE PROTECTIVE PIECE; HOWEVER, THE SURGEON SUCCESSFULLY IMPLANTED IT WITH EXTRA CAUTION, AND THE BUTTON DID NOT SNAP. THE DELAY WAS APPROXIMATELY FIVE MINUTES TO OPEN THE AR-2291 REPLACEMENT. BONE QUALITY WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759250 ↗
• MalfunctionMar 7, 2024Break; Break

  IT WAS REPORTED THAT DURING A REFIXATION OF THE LONG BICEPS TENDON THE IMPLANT BROKE OFF WHEN THE SURGEON INSERTED IT. THE BROKEN PIECE WAS RETRIEVED OUT OF THE PATIENT AND THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE DW 29-FEB-2024: IT WAS FURTHER REPORTED THAT THE THREAD OF THE INSERTER BROKE OFF. THE IMPLANT HAS BEEN IMPLANTED CORRECTLY. THE BROKEN THREAD WAS REMOVED. THE OPERATION WAS SUCCESSFULLY COMPLETED WITH THE SAME IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 18858565 ↗
• MalfunctionJul 6, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROXIMAL BICEPS TENDON REFIXATION SURGERY THE BUTTON COULDN`T BE DETACHED (ROTATED) FROM THE INSERTER. THE THREAD IS BROKEN OFF ON BOTH ITEMS. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE (B)(6) 2023: IT WAS CONFIRMED THAT THE DEVICES BROKE INSIDE THE PATIENT AND ALL FRAGMENTS COULD BE RETRIEVED FROM THE PATIENT. UPDATE AVOE (B)(6) 2023: IT WAS CONFIRMED THAT THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICES WITH THE SAME PART NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266721 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2023 BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3636 FIBERTAK AND AR-2291 BUTTON ARE INVOLVED IN A PATIENT INFECTION, SOURCE OF INFECTION UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16223361 ↗
• MalfunctionAug 8, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2291 PROXIMAL TENODESIS BUTTON BROKE OFF THE INSERTER. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 15183233 ↗
• MalfunctionFeb 1, 2021Break

  IT WAS REPORTED THAT DURING A PROXIMAL BICEPS TENODESIS SURGERY WHILE INSERTING THE BUTTON THE GRUB SCREW BROKE OFF. THE REMAINED INSIDE THE BUTTON. THE SURGERY WAS FINISHED SUCCESSFULLY AND IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11258732 ↗