Tornier Flex MWF113Recalls & reported problems
Tornier · Retroversion Rod · Class 1
All models of Tornier Flex (15)
Data updated Oct 16, 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 03700386975011), received between Mar 25, 2022 and Aug 21, 2025 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Limb Fracture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 21, 2025Break; Fracture; Break; Fracture
THE INSTRUMENT BROKE DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22862086 ↗MalfunctionSep 6, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE DISENGAGEMENT OF THE DISTAL BODY OF THE TRIAL STEM FROM THE PROXIMAL BODY, WITH THE RETROVERSION ROD STILL ATTACHED TO THE INTRODUCER HANDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY FRACTURING THE HUMERUS PROXIMALLY, REMOVING THE REMAINING PART OF THE TRIAL STEM INSIDE AND RE-TRAILING WITH A NEW CONSTRUCT, FOLLOWED BY THE FINAL IMPLANT. THIS RESULTED IN A 45 MIN DELAY.
Patient problems: Limb Fracture
MAUDE report 15362519 ↗MalfunctionMar 25, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT WHILE IMPLANTING THE FINAL REVIVE IMPLANT THE BROKE OFF WITH THE TIP STILL THREADED IN. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13911531 ↗
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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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