RENOVATION 71369200Recalls & reported problems
Smith & Nephew, Inc. · RONGEUR 200MM WITH TEETH · Class 1
All models of RENOVATION (16)
Data updated Oct 16, 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 03596010406408), received between Apr 14, 2019 and Mar 14, 2026 — 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. 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
- Break2
- Defective Component1
- Fracture1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2026Fracture; Material Twisted/Bent
IT WAS REPORTED THAT, DURING A THR, THE TIP OF ONE (1) RONGEUR 200MM W/TEETH BROKE. THE PIECE THAT CLAMPS DOWN WAS BENT 15-20° TO ONE SIDE. NO PIECES BROKE OFF INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24600347 ↗MalfunctionDec 14, 2021Break; Break
IT WAS REPORTED THAT A CEMENT DRILL 4.5MM ((B)(4)) BROKE INSIDE THE PATIENT, A RONGEUR 300MM WITH TEETH ((B)(4)) AND A RONGEUR 200MM WITH TEETH ((B)(4)) ARE BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13002426 ↗MalfunctionNov 23, 2020Break; Break
IT WAS REPORTED THAT THE RONGEUR 200MM W/TEETH HAS THE TEETH BROKEN. NO CASE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10888741 ↗MalfunctionApr 14, 2019Defective Component; Defective Component
IT WAS REPORTED THAT BEFORE THE TEETH ARE SPREADING WHEN PRESSURE IS APPLIED. NO INJURIES OR DELAYS REPORTED. NO MORE INFORMATION AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8512583 ↗
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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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