Arthrex® AR-6572Recalls & reported problems
Arthrex, Inc. · ARTHREX GEMINI SR8 · Class 1
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867040434), received between Jun 6, 2022 and Feb 24, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break5
- Leak/Splash1
Patient problems
- Insufficient Information3
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2026Break; Leak/Splash
ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6572 CANNULA VALVE BROKE AND WATER SPURTED OUT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24428150 ↗MalfunctionAug 19, 2025Break; Break
ON 8/1/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT DURING ARTHROSCOPIC SURGERY IN (B)(6) 2025, THE SURGEON INSERTED AN AR-6572 ARTHREX GEMINI SR8 SELF-RETAINING CANNULA SYSTEM WITH A DISPOSABLE CANNULATED OBTURATOR AND A NO-SQUIRT CAP. DURING INSERTION, THE CANNULA BROKE, LEAVING A PIECE OF THE DEVICE INSIDE THE PATIENT. THE SURGEON SUCCESSFULLY LOCATED AND REMOVED THE BROKEN FRAGMENT WITHOUT FURTHER COMPLICATIONS.
Patient problems: Insufficient Information
MAUDE report 22840191 ↗MalfunctionJul 26, 2024Break; Break
ON 7/8/2024, A MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-6572 ARTHREX GEMINI SR8 HAD ONE OF THE TWO PRONGS BREAK OFF IN THE PATIENT INTRAOPERATIVELY. THE SURGEON IDENTIFIED IT, FOUND THE PIECE, REMOVED IT, COMPARED IT TO ANOTHER PORT, AND THEN PROCEEDED TO FINISH THE CASE. PER THE FACILITY REPRESENTATIVE, THE CANNULA SYSTEM IS NOT METAL AND WOULD NOT APPEAR ON THE X-RAY. THIS WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2024.
Patient problems: Insufficient Information
MAUDE report 19843031 ↗MalfunctionNov 20, 2023Break; Break
ON 10/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06068646 THAT AN AR-6572 CANNULA WINGS ON THE BLUE PLASTIC PART SEEMED TO BE BROKEN. THIS OCCURRED DURING A CASE ON (B)(6) 2023 PRIOR TO INSERTING THE ANCHOR. THE CASE WAS COMPLETED USING A DIFFERENT CANNULA.
Patient problems: Insufficient Information
MAUDE report 18172495 ↗MalfunctionJun 6, 2022Break
ON 05/17/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-6572 CANNULA BROKE. THIS OCCURRED DURING AN UNKNOWN CASE WHEN THE WINGS ON THE GEMINI BROKE-OFF IN THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 14603841 ↗
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- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
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- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.