R3 71363420Recalls & reported problems
Smith & Nephew, Inc. · R3 0 DEGREE 40MM INNER DIAMETER PERMANENT TRIAL LINER 56MM OUTER DIAMETER · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556110997), received between Nov 24, 2020 and Sep 19, 2024 — classified as 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING THR SURGERY, A R3 0 DEG 40ID PERM TRL LNR 560D BROKE DURING EXTRACTION. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20256977 ↗MalfunctionOct 26, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING THR SURGERY, AN R3 0 DEG 40ID PERM TRL LNR 560D BROKE IN HALF. 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 15674889 ↗MalfunctionApr 6, 2022Break; Break
IT WAS REPORTED THAT 2 OF 4 TABS ON R3 0 DEG 40ID PERM TRL LNR 560D WERE FOUND BROKEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14018524 ↗MalfunctionNov 24, 2020Break; Break
IT WAS REPORTED THAT A TRIAL PIECE HAS BROKEN OFF OF IT. IT WAS NOTICED DURING SERVICE/PM, THEREFORE NO CASE OR PATIENT WAS INVOLVED. NO INJURY, NO DELAY, NO BACKUP NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10897452 ↗
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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