Tornier Humeral Nail SH93759Recalls & reported problems
Tornier, Inc. · LOCKING LEVER · Class 1
Data updated Oct 18, 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 00846832022489), received between Aug 18, 2023 and Aug 15, 2024 — classified as 2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture2
- Detachment of Device or Device Component1
- Naturally Worn1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 15, 2024Break; Fracture; Break; Fracture
IT WAS REPORTED THAT TWO PIECES IN THE TRAY WERE NOT FUNCTIONING PROPERLY. THEY ARE BROKEN AND NEED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19994170 ↗MalfunctionAug 18, 2023Break; Fracture; Detachment of Device or Device Component; Naturally Worn; Break; Fracture; Detachment of Device or Device Component; Naturally Worn
THE SIGHTING NAIL GUIDE IS BROKEN, AS IS A LOCKING LEVER. A PIECE IS STILL IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 17578402 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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