Titan™ ROD-0923-040-001Recalls & reported problems
Ascension Orthopedics, Inc. · Titan™ Total Shoulder System The handle is used with the head cutting template. · Class 1
All models of Titan (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780247302), received between Aug 31, 2022 and Oct 4, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Most reported problems
Device problems
- Fracture2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 4, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A SHOULDER SURGERY, THE THREADED TIP OF A TSS HEAD CUTTING TEMPLATE ROD. 2.5 BROKE OFF WHILE TRYING TO SCREW IT INTO THE INSERTER/IMPACTOR. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15537892 ↗MalfunctionAug 31, 2022Fracture; Break; Fracture
IT WAS REPORTED THAT DURING SHOULDER SURGERY THE TSS HEAD CUTTING TEMPLATE ROD. 2.5 BROKE OFF IN THE INSERTER. NO INJURY OR DELAY REPORTED. IT IS UNKNOWN HOW THIS SURGERY FINISHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15326855 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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