N/A 72203791FRecalls & reported problems
Smith & Nephew, Inc. · RFB TRUEPASS SUTURE PASSER SELF-CAPTUR · Class 1
Data updated Oct 16, 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 00885554036657), received between May 8, 2018 and Oct 24, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Unstable1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2025Unstable; Unstable
IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, IT WAS NOTICED THAT A RFB TRUEPASS SUTURE PASSER SELF-CAPTUR SPRING ON THE TIP BECAME LOOSE. THE PROCEDURE WAS PERFORMED, AFTER A DELAY GREATER THAN 30 MIN, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23382219 ↗MalfunctionMay 8, 2018Break
IT WAS REPORTED THAT SELF CAPTURE PIECE IS BROKEN. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7494316 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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