AETOS Shoulder System SCR-0990-822Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00885556812099), received between Sep 19, 2023 and Jun 3, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Fracture” (17 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 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Fracture; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT, DURING A TSA SURGERY, THE CONNECTION OF FOUR (4) GLENOID REAMER DRIVER BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25381013 ↗
• MalfunctionJun 3, 2026Fracture; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT, DURING A TSA SURGERY, THE CONNECTION OF FOUR (4) GLENOID REAMER DRIVER BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25380958 ↗
• MalfunctionJun 3, 2026Fracture; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT, DURING A TSA SURGERY, THE CONNECTION OF FOUR (4) GLENOID REAMER DRIVER BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25380638 ↗
• MalfunctionMay 28, 2026Fracture

  IT WAS REPORTED THAT, DURING A TSA SURGERY, WHEN THE REAMING WAS STARTED THE TORX AT THE END OF ONE (1) GLENOID REAMER DRIVER SNAPPED OFF. THE BROKEN PIECE FELL ON THE FLOOR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (USING THE T HANDLE AND REAMING THE GLENOID BY HAND). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25318566 ↗
• MalfunctionMay 1, 2026Fracture; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT, DURING A TSA SURGERY, THE CONNECTION OF FOUR (4) GLENOID REAMER DRIVER BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058913 ↗
• MalfunctionNov 13, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING A TOTAL SHOULDER ARTHROPLASTY, IT WAS NOTICED THAT ONE (1) GLENOID REAMER DRIVERS BROKE DURING REAMING. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543856 ↗
• MalfunctionOct 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TOTAL SHOULDER ARTHROPLASTY, IT WAS NOTICED THAT TWO (2) GLENOID REAMER DRIVERS BROKE DURING REAMING. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23264866 ↗
• MalfunctionMar 18, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING REVERSE SHOULDER ARTHROPLASTY, ONE (1) GLENOID REAMER DRIVER SNAPPED INSIDE THE REAMER WHILE REAMING THE GLENOID. ALL PIECES WERE MAINTAINED INSIDE THE GLENOID REAMER SHAFT WHICH WAS HANDED OFF. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21628096 ↗
• MalfunctionFeb 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING REVERSE SHOULDER ARTHROPLASTY, ONE (1) GLENOID REAMER DRIVER TIP SNAPPED OFF INSIDE THE REAMER WHILE REAMING THE GLENOID. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21292676 ↗
• MalfunctionSep 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AETOS ANATOMICAL SHOULDER SURGERY, THE STAR TIP OF ONE (1) GLENOID REAMER DRIVER BROKE. BROKEN PIECE WAS REMOVED ON BACK TABLE BEFORE PROCEEDING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302397 ↗
• MalfunctionSep 18, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANATOMIC TSA, THE GLENOID REAMER DRIVER BENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245478 ↗
• MalfunctionAug 23, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN AETOS PROCEDURE, ONE (1) GLENOID REAMER DRIVER FRACTURED IN THE REAMER HANDLE, WHICH CAUSED GLENOID REAM BIT BP CENTERED TO STOP BEING "SMOOTH" AND BINDING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20045755 ↗
• MalfunctionJul 1, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROPLASTY SURGERY, THE THREADS OF THE GLENOID REAMER DRIVER STRIPPED OFF. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19651257 ↗
• MalfunctionApr 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT, WHEN THE SURGEON WAS REAMING DURING A TOTAL SHOULDER SURGERY, TWO (2) GLENOID REAMER DRIVER SNAPPED. DOCTOR COMPLETED WITH REAMING AS THE SECOND WAS DEFICIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028853 ↗
• MalfunctionFeb 12, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING SHOULDER REPLACEMENT SURGERY, A PIECE OF ONE (1) GLENOID REAMER DRIVER BROKE INTRAOPERATIVELY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684663 ↗
• MalfunctionNov 17, 2023Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING A RSA PROCEDURE, WHEN A GLENOID REAMER DRIVER WAS BEING USED, THE PROXIMAL DRIVER TIP BROKE OFF INTO THE DRIVER JUNCTION. NO PIECE FELL INTO THE PATIENT. SINCE THE TIP OF THE DRIVER BROKE, THE REAMER WOULD NO LONGER SPIN. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, BY USING A HIGH SPEED BURR TO CONTINUE REAMING. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18160061 ↗
• MalfunctionNov 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TSA, THE PHYSICIAN WAS USING THE 15 DEGREE REAMERS, AFTER LEANING INTO THE INSTRUMENT, THE TIP OF THE GLENOID REAMER DRIVER BROKE OFF INTO THE END OF THE REAMER BIT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149564 ↗
• MalfunctionSep 19, 2023Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING A REVERSE SHOULDER ARTHROPLASTY, THE TIP OF A GLENOID REAMER DRIVER SNAPPED, WHILE REAMING, WHEN THE REAMER MADE CONTACT WITH THE FUKUDA RETRACTOR. ALL PIECES WERE RECOVERED AS THEY WERE CONTAINED INSIDE THE DRIVER SHAFT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775023 ↗