Tornier Latitude 9030155Recalls & reported problems
Tornier, Inc. · Flexible Reamer · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846832020072), received between Oct 28, 2025 and Oct 28, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2025Fracture; Fracture
IT WAS REPORTED THAT THE LATITUDE EV KIT WAS USED. WHEN USING 2 OF THE FLEXIBLE REAMERS ON THE KIT THEY SNAPPED/ BROKE AND THEREFORE WILL NEED REPLACING ON THE KIT. UPON REAMING OVER THE GUIDE WIRE WHEN REMOVING THE REAMER 1 HAD SNAPPED IN HALF, THE SECOND HAD SNAPPED BUT DID NOT COME APART. BOTH REAMERS WERE REMOVED SUCCESSFULLY INCLUDING LOOSE ITEMS DUE TO THE BALL TIPPED WIRE AND NOTHING WAS LEFT IN THE PATIENT. IT WAS REPORTED THAT; THE REAMERS WERE FINISHED WITH SO NOT NEEDED AGAIN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23405626 ↗
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- NA 05.001.223Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT397 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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