Arthrex® AR-2267Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867026544), received between Aug 11, 2016 and May 15, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SURGEON WANTED TO USE TWO AR-2267 BUTTONS FOR A PEC REPAIR. THE REP OPENED TWO SEPARATE AR-2267. THE BUTTONS WERE ORIGINALLY ON THE INSERTERS WHEN OPENED BUT WHEN BEGAN PUTTING SUTURE THREW THEY FELL OFF AND WOULD NOT RELOAD ONTO THE INSERTER. AR-2269 WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE ONES IN THE AR-2269 PACKAGE HAD NO ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 19322665 ↗
• MalfunctionMay 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SURGEON WANTED TO USE TWO AR-2267 BUTTONS FOR A PEC REPAIR. THE REP OPENED TWO SEPARATE AR-2267. THE BUTTONS WERE ORIGINALLY ON THE INSERTERS WHEN OPENED BUT WHEN BEGAN PUTTING SUTURE THROUGH THEY FELL OFF AND WOULD NOT RELOAD ONTO THE INSERTER. AR-2269 WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE ONES IN THE AR-2269 PACKAGE HAD NO ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 19322577 ↗
• MalfunctionMay 1, 2024Break; Break

  ON 12/27/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2267 THREADED PORTION OF THE BUTTON INSERTER SNAPPED OFF. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME ON 12/27/2021. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220727 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem

  SALES REP ADVISED THAT, "ON WEDNESDAY OCTOBER 27TH AT 5PM I RECEIVED AN EMAIL FROM ARTHREX CUSTOMER SERVICE. SHE HAD RECEIVED A CALL FROM (B)(6) HOSPITAL. HE EXPLAINED THAT A PATIENT HAD PRESENTED WITH INFECTION ISSUES ARISING FROM A PREVIOUS SUB PECTORAL BICEPS TENODESIS USING A LARGE PEC BUTTON FROM ARTHREX. HE DID NOT STATE WHEN THE SURGERY OCCURRED. HE WAS CALLING TO ASK WHAT THE MATERIAL IS OF THE LARGE PEC BUTTON AND SUTURE MATERIAL. I STATED THE MATERIAL MAKE UP (TITANIUM AND ULTRA HIGH MOLECULAR POLYETHYLENE SUTURE).

  Patient problems: Unspecified Infection

  MAUDE report 12814506 ↗
• InjuryFeb 28, 2018Break

  IT WAS REPORTED THAT DURING A PEC REPAIR THE LARGE PEC BUTTON, AR-2267 KEPT ON BREAKING THE FIBER TAPE AND WOULD NOT SLIDE THROUGH. THE BUTTON REMAINS IN PATIENT AND WAS SECURED UNI CORTICAL. DUE TO THE ISSUE WITH THE FIRST PEC BUTTON THE SURGEON HAD TO DRILL ANOTHER PILOT HOLE AND INSERT ANOTHER LARGE PEC BUTTON TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT ANY FURTHER INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7302195 ↗
• InjuryAug 11, 2016Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT OPEN PECTORALIS MAJOR TENDON PRIMARY REPAIR ON (B)(6) 2015. A SECOND SURGERY WAS PERFORMED ON (B)(6) 2016 DUE TO REACTION SYMPTOMS, NO PRODUCTS EXPLANTED. PROCEDURE CULTURE RESULTS NEGATIVE. POST-OP (B)(6) 2016 SURGERY, PATIENT REPORTED A BUMP AND INCREASED DRAINAGE FROM A REGION IN THE UPPER ARM. HE INITIALLY SAW A DERMATOLOGIST WHO PERFORMED A LOCAL BIOPSY, WHICH ALSO SHOWED NEGATIVE/NO GROWTH. SHORTLY AFTER BIOPSY BUMP AREA BEGAN LEAKING PUS/BLOOD WITH GRANULATED TISSUE. AN URGENT CARE FACILITY ADMINISTERED IV (CLINDAMYCIN AND PRESCRIBED ORAL CLINDAMYCIN). SURGEON INSTRUCTED PATIENT TO FOLLOW THE ORAL ANTIBIOTIC REGIMEN AND PUT PRESSURE ON THE AFFECTED AREA 4 TIMES DAILY TO DRAIN THE PUS AS MUCH AS POSSIBLE. ON (B)(6) 2016 PATIENT SAW HIS ORIGINAL SURGEON. PATIENT'S MEDICAL RECORDS NOTED PATIENT HAS A DRAINING SINUS TRACT, EXPRESSING SOME THICK DRAINAGE, ALTHOUGH NO FOUL-SMELLING FLUID WAS ENCOUNTERED. RECORDS NOTED NO CONSTITUTIONAL SYMPTOMS (FEVERS, SHAKES OR CHILLS), INCISION APPEARED INTACT WITH PATIENT HAVING SOME DISCOMFORT ABOUT THE UPPER EXTREMITY, WHICH WAS NOTED TO HAVE BEEN IMPROVING WITH DRAINAGE FROM THE REGION. EXAMINAT

  Patient problems: Discomfort; Purulent Discharge; Swelling; Unspecified Infection

  MAUDE report 5867958 ↗
• InjuryAug 11, 2016Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT OPEN PECTORALIS MAJOR TENDON PRIMARY REPAIR ON (B)(6) 2015. A SECOND SURGERY WAS PERFORMED ON (B)(6) 2016 DUE TO REACTION SYMPTOMS, NO PRODUCTS EXPLANTED. PROCEDURE CULTURE RESULTS NEGATIVE. POST-OP (B)(6) 2016 SURGERY, PATIENT REPORTED A BUMP AND INCREASED DRAINAGE FROM A REGION IN THE UPPER ARM. HE INITIALLY SAW A DERMATOLOGIST WHO PERFORMED A LOCAL BIOPSY, WHICH ALSO SHOWED NEGATIVE/NO GROWTH. SHORTLY AFTER BIOPSY BUMP AREA BEGAN LEAKING PUS/BLOOD WITH GRANULATED TISSUE. AN URGENT CARE FACILITY ADMINISTERED IV (CLINDAMYCIN AND PRESCRIBED ORAL CLINDAMYCIN). SURGEON INSTRUCTED PATIENT TO FOLLOW THE ORAL ANTIBIOTIC REGIMEN AND PUT PRESSURE ON THE AFFECTED AREA 4 TIMES DAILY TO DRAIN THE PUS AS MUCH AS POSSIBLE. ON (B)(6) 2016 PATIENT SAW HIS ORIGINAL SURGEON. PATIENT'S MEDICAL RECORDS NOTED PATIENT HAS A DRAINING SINUS TRACT, EXPRESSING SOME THICK DRAINAGE, ALTHOUGH NO FOUL-SMELLING FLUID WAS ENCOUNTERED. RECORDS NOTED NO CONSTITUTIONAL SYMPTOMS (FEVERS, SHAKES OR CHILLS), INCISION APPEARED INTACT WITH PATIENT HAVING SOME DISCOMFORT ABOUT THE UPPER EXTREMITY, WHICH WAS NOTED TO HAVE BEEN IMPROVING WITH DRAINAGE FROM THE REGION. EXAMINAT

  Patient problems: Discomfort; Granuloma; Necrosis; Pain; Purulent Discharge; Reaction

  MAUDE report 5867957 ↗