Arthrex® AR-2266Recalls & reported problems
Arthrex, Inc. · BUTTON, PEC REPAIR · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867026537), received between Feb 17, 2021 and Feb 17, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
Patient problems
- Loss of Range of Motion1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2021Break
IT WAS REPORTED BY A PATIENT'S LEGAL REPRESENTATIVE THAT ON (B)(6) 2018 THE PATIENT UNDERWENT A RIGHT SHOULDER ARTHROSCOPIC REPAIR OF THEIR ROTATOR CUFF. DURING THE SURGERY THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED; AR-2324BCC (LOT: UNKNOWN) QTY. 1 // BIOCOMPOSITE SWIVELOCK SUTURE ANCHOR. AR-2266 (LOT: 10146727) QTY. 1 // PEC BUTTON. THE OPERATIVE REPORT INDICATES THERE WERE NO APPARENT COMPLICATIONS AND THAT THE SURGERY WENT AS EXPECTED. POST-SURGERY, THE PATIENT WAS EXPECTEDLY LIMITED AND RESTRICTED IN MOST FUNCTIONS. BY ALL ACCOUNTS, THE PATIENT'S SHOULDER WAS DOING "GREAT" UP UNTIL (B)(6) 2019 - WHICH WAS ABOUT 1 YEAR AND 8 MONTHS POST-OP. ON THIS DATE, THE PATIENT REPORTED THAT THEY WERE SIMPLY "TOWELING OFF'' THEIR BACK AFTER A SHOWER AND FELT/HEARD AN AUDIBLE "POP" IN THEIR RIGHT SHOULDER ACCOMPANIED BY AN EXCRUCIATING PAIN. THE PATIENT ALSO BEGAN TO EXPERIENCE A FREEZING/PARALYZING SENSATION IN THEIR SHOULDER. THIS CAUSED THE PATIENT TO RETURN TO THEIR SURGEON FOR EVALUATION/TREATMENT. THE SURGEON EVALUATED THE PATIENT AND NOTED THE TERRIBLE PAIN THEY WERE EXPERIENCING. THE SURGEON ORDERED RADIOLOGY OF THE PATIENT'S SHOULDER, WHICH DID NOT REVEAL ANY APPARENT FRACTURES
Patient problems: Loss of Range of Motion; Pain
MAUDE report 11339060 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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