AETOS Shoulder System SCR-0990-862Recalls & reported problems
Smith & Nephew, Inc. · T-20 DRIVER FOR 4.5MM SCREWS · Class 2
All models of AETOS Shoulder System (44)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00885556812235), received between Jul 1, 2024 and Dec 22, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture5
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 22, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A AETOS SHOULDER SURGERY, THE TIP OF ONE (1) T-20 DRIVER 4.5MM PERIPHERAL SCREWS BROKE OFF AFTER PUTTING LAST SCREW IN. DRIVER TIP DID NOT FALL INTO PATIENT. PIECE WAS RETRIEVED BY HAND. THE PROCEDURE WAS ALREADY COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23872356 ↗MalfunctionNov 14, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TSA SURGERY, ONE (1) T-20 DRIVER 4.5MM PERIPHERAL SCREWS IS BROKEN OFF. NO PIECE FELL INSIDE PATIENT'S WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23556927 ↗MalfunctionAug 2, 2025Fracture; Material Deformation; Fracture; Material Deformation
IT WAS REPORTED THAT DURING A REVERSE SHOULDER ARTHROPLASTY, THE TIP OF THE T-20 DRIVER 4.5MM PERIPHERAL SCREWS SNAPPED OFF WHILE TIGHTENING THE PERIPHERAL LOCKING SCREW, THE BROKEN TIP WAS REMOVED BY SUCTION. 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 22694155 ↗MalfunctionSep 10, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A TSA SURGERY, THE DISTAL TIP OF ONE (1) T-20 DRIVER 4.5MM PERIPHERAL SCREWS WAS TWISTED OFF WHILE USING ONE (1) GLENOSPHERE REMOVAL TOOL 42. THE FRACTURED PIECE WAS CONTAINED WITHIN THE REMOVAL TOOL, AND IT WAS RETRIEVED FROM THE TOOL ON THE BACK TABLE AFTER SURGERY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20186654 ↗MalfunctionJul 1, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A REVERSE SHOULDER ARTHROPLASTY, UPON TIGHTENING A LOCKING SCREW INTO A BASEPLATE, THE TIP OF THE T-20 DRIVER 4.5MM PERIPHERAL SCREWS SNAPPED. THE PIECE THAT FELL INSIDE THE PATIENT WAS REMOVED USING SUCTION. THE PROCEDURE WAS PERFORMED, AFTER NO 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 19644938 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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