Arthrex® AR-9803A-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867062726), received between May 10, 2018 and Oct 10, 2024 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2024Break; Break

  ON 10/09/2024 ADDITIONAL INFORMATION WAS RECEIVED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL WHO STATED THAT THE PROCEDURE PERFORMED WAS A SHOULDER ARTHROSCOPY. THE ABLATOR MELTED ONE OF THE TIPS, THE MELTED MATERIAL CAME LOOSE AND STUCK TO THE OPTICAL SYSTEM. PHOTOS ARE ATTACHED. AN ARTHREX REP WAS NOT PRESENT DURING THE PROCEDURE. THE ABLATOR WAS ONLY IN USE DURING THE BEGINNING OF THE PROCEDURE. THE PATIENT'S BONE QUALITY WAS GOOD. THERE WAS NO INSTRUMENT USED TO PREPARE THE BONE SOCKET. NOT ALL FRAGMENTS WERE ABLE TO BE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY DELAY OR NEED FOR ADDITIONAL ANESTHESIA.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20418821 ↗
• MalfunctionApr 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ISOLATION CAME LOOSE DURING SHOULDER ARTHROSCOPY. NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. 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. UPDATE SWIT 08-FEB-2021: NOTHING GOT INTO THE PATIENT. DURING UNPACKING, IT WAS NOTICED THAT THE BLUE ISOLATION HAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19081947 ↗
• MalfunctionMay 8, 2023Break; Break

  IT WAS REPORTED ON (B)(6) 2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9803A-90 COOLCUT ABLATOR SUCTION ADAPTOR CONTINUOUSLY BREAKS OFF. CASE INVOLVEMENT, DEVICE BREAKS DURING USE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885312 ↗
• MalfunctionJan 9, 2023Smoking; Smoking; Sparking

  IT WAS REPORTED THAT THE HEAD OF THE DEVICE SPARKED AND SMOKED AND CHARRED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED BEFORE THE SURGERY. NO FURTHER INFORMATION RECEIVED. UPDATE (B)(6) 2023. IT WAS CONFIRMED THAT THE DEVICE WAS USED WITH A GENERATOR FROM ANOTHER MANUFACTURER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120590 ↗
• InjuryMay 10, 2018Fire; Sparking

  IT WAS REPORTED THAT WHEN THE HOSPITAL MEDICAL DEVICE (OPES) WAS ACTIVATED IN THE ARTICULAR CAVITY OF THE PATIENT'S LEFT SHOULDER, THE ARTHROSCOPIC TOWER MONITOR SHOWED FLAMES AND SPARKS LEAVING THE CURVATURE OF THE DISTAL TIP OF THE RADIOFREQUENCY TIP. IT WAS OBSERVED THAT IN THIS CURVATURE THE PLASTIC PROTECTION FAILED. AT THIS TIME, NO NEW INFORMATION WAS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7502460 ↗