Arthrex® AR-2269Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867026582), received between Jun 21, 2017 and Aug 25, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 07/29/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT A PATIENT DEVELOPED AN INFECTION AFTER UNDERGOING A PECTORALIS MAJOR PROCEDURE ON (B)(6) 2025 WHERE AN AR-2269 IMPLANT DELIVERY SYSTEM WAS UTILIZED. ADDITIONAL INFORMATION WAS PROVIDED ON 07/29/2025 WHERE THE SALES REPRESENTATIVE STATED THIS OCCURRED 8 DAYS POST OP ON (B)(6) 2025 INFECTION DISCOVERED. THE INFECTION BEING TREATED, AND THE PATIENT IS RECOVERING.

  Patient problems: Unspecified Infection

  MAUDE report 22882869 ↗
• InjuryJul 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT¿S RELATIVE REPORTED VIA PHONE THAT HER HUSBAND DEVELOPED AN INFECTION AFTER A PECTORALIS MAJOR TENDON REPAIR PROCEDURE OF THE LEFT PECTORALIS ON (B)(6) 2025. THREE UNKNOWN PEC BUTTONS WERE IMPLANTED IN THE PATIENT. 2 WEEKS AFTER SURGERY, THE PATIENT HAD AN INFECTION AND WAS PUT ON ANTIBIOTICS. IN EARLY (B)(6), THE PATIENT STARTED TO HAVE ISSUES AGAIN, AND HE DEVELOPED A MASS ON HIS BICEPS, A GRANULOMA, THAT WOULD NOT HEAL. AN MRI WAS TAKEN, AND IT SHOWED EDEMA. ON (B)(6) 2025, A SECOND SURGERY WAS PERFORMED BY THE SAME SURGEON TO CLEAR THE INFECTION; NOTHING WAS EXPLANTED OR IMPLANTED. ANTIBIOTICS WERE ADMINISTERED DURING THE PROCEDURE, AND SAMPLES WERE TAKEN, WHICH CAME BACK NEGATIVE FOR INFECTION. THE SURGERY WAS DEEMED SUCCESSFUL. THE MASS ON THE PATIENT¿S ARM IS STILL PRESENT; IT IS AN OPEN WOUND WITH SUBCUTANEOUS FAT PROTRUDING THROUGH IT. METAL ALLERGY TESTING HAD BEEN PERFORMED. THE PATIENT TESTED POSITIVE FOR COBALT ALLOY. THE PATIENT WILL SEE A WOUND SPECIALIST TO HELP WITH WOUND CLOSURE. THE PATIENT¿S RELATIVE REQUESTED THE MATERIAL COMPOSITION OF THE UNKNOWN IMPLANTS AND A METAL-IMPLANTS-AND-NICKEL-SENSITIVITY DOCUMENT. ADDITIONAL INFORMATION WA

  Patient problems: Foreign Body Reaction

  MAUDE report 22508951 ↗
• MalfunctionJun 10, 2024Defective Device; Defective Device

  ON 4/11/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) PEC BUTTONS FROM AN AR-2269 PEC BUTTON IMPLANT SYSTEM COULD NOT BE TWISTED OFF OR LOOSENED TO DEPLOY. ANOTHER AR-2269 PEC BUTTON IMPLANT SYSTEM WAS USED TO COMPLETE THE CASE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE ON 3/28/2023. ADDITIONAL INFORMATION RECEIVED ON 4/13/2032: THIS WAS DISCOVERED DURING A PEC REPAIR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19506263 ↗
• MalfunctionMay 13, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 04/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06542677 THAT THE BUTTON INSERTERS FROM AN AR-2269 PEC REPAIR IMPLANT DELIVERY SYSTEM WERE BENT TO THE POINT THAT THE BUTTON STRUGGLED TO UNSCREW FROM THE STYLET. THE CASE WAS COMPLETED BY OPENING INDIVIDUAL BUTTONS. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PEC REPAIR PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 4/25/2024: THE PROCEDURE OCCURRED ON (B)(6) 2024. THE CASE WAS NOT DELAYED. ADDITIONAL ANESTHESIA WAS UNNECESSARY, AND THE PATIENT SUFFERED NO NEGATIVE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19300417 ↗
• InjuryJun 21, 2017Component Missing; Device Or Device Fragments Location Unknown

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT DURING A PECTORALIS MAJOR TENDON REPAIR THE LARGE PEC BUTTON KIT WAS USED. AFTER INSERTION OF THE PEC MAJOR LARGE EYELET INTO THE HUMERUS USING A PEC REPAIR IMPLANT DELIVERY SYSTEM, IT WAS NOTICED THAT ONE OF THE STYLETS USED IN THE PROCESS WAS MISSING A THREADED PORTION. THE MISSING PORTION MEASURED APPROXIMATELY 2 X 1 MM. THE WOUND WAS EXPLORED AND THE FRAGMENT WAS NOT FOUND.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6656266 ↗