Titan Reverse Shoulder System INS-0961-049-01Recalls & reported problems
Smith & Nephew, Inc. · RSS REAMER GUIDE BODY INSERTER / EXTRACTOR · Class 1
All models of Titan Reverse Shoulder System (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556864012), received between Jan 7, 2024 and Jul 30, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Degraded1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50090283 ↗MalfunctionSep 9, 2024Break; Break
IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, A RSS REAMER GUIDE BODY INSRTR/EXTRCTR BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20170845 ↗MalfunctionJan 7, 2024Break; Degraded; Break; Degraded
IT WAS REPORTED THAT ONE (1) RSS REAMER GUIDE BODY INSRTR/EXTRCTR IT'S BROKEN AT THE INTERFACE WITH THE REAMER BODY AND DOESN¿T ALLOW THE BODY TO SCREW DOWN TIGHT AND THE METAL WAS WORN DOWN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18461335 ↗
Other Orthopedic manual surgical instrument devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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.
How reports and recalls are matched · Editorial policy · Report an error on this page