CUFF STITCH 7209160Recalls & reported problems
Smith & Nephew, Inc. · CUFF STITCH 180 DEG RIGHT · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010448910), received between Jun 23, 2018 and Jan 10, 2024 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Material Separation1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2024Break; Break
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, IN WHICH WAS NECESSARY TO CREATE A LATERAL PORTAL TO USE A CURVED FORCEPS, A CUFF STITCH BROKE INSIDE THE PATIENT´S JOINT, THE PIECE WAS EASILY REMOVED USING A KELLY CLAMP. SURGERY CONTINUED WITHOUT ANY DELAY WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18489239 ↗InjuryJul 13, 2021Break; Break
IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE "CUFF STITCH 180° RIGHT" TWISTED INSIDE THE PATIENT. THE PRODUCT BROKE INSIDE THE PATIENT AND THE BROKEN PIECE WAS REMOVED USING A CLAMP. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12160695 ↗MalfunctionSep 22, 2019Material Separation; Material Separation
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE DEVICE BROKE. BROKEN PIECES WERE REMOVED FROM PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO DELAY OR PATIENT INJURIES WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9102258 ↗MalfunctionJun 29, 2018Break
IT WAS REPORTED THAT THE DEVICE BROKE AS THE SURGEON DID THE SUTURE. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7652943 ↗MalfunctionJun 23, 2018Break
IT WAS REPORTED THAT THE CUFF STITCH WAS BROKEN IN THE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7632493 ↗
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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 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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