Arthrex® AR-1255-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867006539), received between Jan 11, 2022 and Mar 9, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Break

  ON 16TH FEBRUARY 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1255-18, SUTURE PASSING WIRE, THE NITINOL LOOP BROKE. THIS WAS DETECTED DURING A MENISCAL ROOT REPAIR PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER SUTURE PASSING WIRE.

  Patient problems: Insufficient Information

  MAUDE report 24543670 ↗
• MalfunctionJun 20, 2025Break; Break

  ON 06/02/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-1255-18 SUTURE PASSING WIRE- PER CUSTOMER - DEVICE IS DEFECTIVE. THE LOOP AT THE END OF THE WIRE BROKE OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298780 ↗
• MalfunctionSep 3, 2024Break; Break

  ON 8/9/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1255-18 SUTURE PASSING WIRE, NITINOL LOOP PORTION, SNAPPED IN HALF AND AN AR-2324PCT PEEK SWIVELOCK EYELET BENT ON ANCHOR. THE ANCHOR DID NOT BREAK. EVERYTHING WAS REMOVED FROM INSIDE THE PATIENT. THE CASE WAS COMPLETED USING AN AR-2324PSLC EEK-SWIVELOCK C. THIS WAS DISCOVERED DURING A TRICEPS REPAIR PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED A FEW MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 20125078 ↗
• MalfunctionAug 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BICEPS TENODESIS SURGERY THE EYELET DETACHED FROM THE DEVICE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 19917055 ↗
• MalfunctionJul 17, 2024Break; Break

  ON 27TH JUNE 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1255-18, SUTURE PASSING WIRE, WAS MISSING THE WIRE LOOP AT THE END OF THE WIRE, THIS WAS DETECTED DURING USE IN A ACROMIOCLAVICULAR JOINT STABILISATION PROCEDURE ON (B)(6) 2024 AND THE MISSING WIRE LOOP WAS NOTICED WHEN AR-1255-18 WAS ADVANCED WHILE IT WAS PLACED THROUGH AR-2256L AND THE CORACOID PASSER WAS PASSED BELOW THE PATIENTS CORACOID. X RAYS DID NOT REVEAL ANY OBVIOUS INDICATION THAT THE MISSING PIECE WAS IN THE PATIENT, BUT IT WAS NOT FOUND IN THE SURROUNDING AREA EITHER. OPERATION PROCEEDED AS PLANNED AND THIS PIECE WAS DOCUMENTED AS MISSING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE PASSING SUTURES WERE TIED TO THE END OF THE NITINOL WIRE AND SHUTTLED ACROSS, INSTEAD OF USING THE WIRE LOOP WHICH HAD DETACHED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19760482 ↗
• MalfunctionJun 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE SURGEON ATTEMPTED TO PASS THE 1.3MM TAPE, 3 AR-1255-18, SUTURE LOOPS WERE TORN OFF IN QUICK SUCCESSION. THE SURGEON USED A NEW PRODUCT TO FINISH THE CASE. NO ADVERSE EFFECT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563742 ↗
• MalfunctionJun 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE SURGEON ATTEMPTED TO PASS THE 1.3MM TAPE, 3 AR-1255-18, SUTURE LOOPS WERE TORN OFF IN QUICK SUCCESSION. THE SURGEON USED A NEW PRODUCT TO FINISH THE CASE. NO ADVERSE EFFECT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563625 ↗
• MalfunctionJun 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE SURGEON ATTEMPTED TO PASS THE 1.3MM TAPE, 3 AR-1255-18, SUTURE LOOPS WERE TORN OFF IN QUICK SUCCESSION. THE SURGEON USED A NEW PRODUCT TO FINISH THE CASE. NO ADVERSE EFFECT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563335 ↗
• MalfunctionJan 11, 2022Break

  ON (B)(6) 2021, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA E-MAIL THAT A AR-1255-18 SUTURE PASSING WIRE BROKE. THIS OCCURRED ON (B)(6) 2021 WHILE BEING USED IN A TFCC I-O METHOD WHEN TWO WIRE LOOPS BROKE IN A ROW. THE CASE WAS COMPLETED USING A NEW PRODUCT, AND THERE WAS NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2021: THE PROCEDURE BEING PERFORMED WAS A TFCC DAMAGE. THE LOOP BROKE DURING PASSING. THE TAPE CAME OUT OF THE BONE HOLE AND DID NOT INTERFERE WITH THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13225889 ↗
• MalfunctionJan 11, 2022Break

  ON 12/23/2021, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA E-MAIL THAT (2) AR-1255-18 SUTURE PASSING WIRES BROKE. THIS OCCURRED ON (B)(6) 2021 WHILE BEING USED IN A TFCC I-O METHOD WHEN TWO WIRE LOOPS BROKE IN A ROW. THE CASE WAS COMPLETED USING A NEW PRODUCT, AND THERE WAS NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION PROVIDED 12/27/2021: THE PROCEDURE BEING PERFORMED WAS A TFCC DAMAGE. THE LOOP BROKE DURING PASSING. THE TAPE CAME OUT OF THE BONE HOLE AND DID NOT INTERFERE WITH THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13225839 ↗