T2 1830-0724SRecalls & reported problems
Stryker GmbH · Humeral Nail · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540201300), received between Aug 27, 2024 and Sep 14, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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. 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
- Break1
- Device Damaged by Another Device1
- Fracture1
- Positioning Failure1
Patient problems
- Failure of Implant1
- Impaired Healing1
- Implant Pain1
- No Clinical Signs, Symptoms or Conditions1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Positioning Failure; Device Damaged by Another Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764172 ↗InjuryAug 27, 2024Break; Fracture; Break; Fracture
AS REPORTED: PATIENT HAD A SHOULDER ROD (NAIL) IMPLANTED IN 2023. ACCORDING TO X-RAY ON (B)(6) 2024 SLOWLY CONSOLIDATING FRACTURE OF THE LOW 3 OF THE RIGHT HUMERUS WITH SECONDARY DISPLACEMENT OF THE FRAGMENT IN THE MOS STATE. FRACTURE OF A METAL STRUCTURE. THE REASON FOR GOING TO THE HOSPITAL WAS PAIN IN THE SHOULDER JOINT. THE PAIN APPEARED IN FEBRUARY 2024 AND GRADUALLY INCREASED". REVISION OPERATION IS PLANNED ON (B)(6) 2024.
Patient problems: Failure of Implant; Impaired Healing; Implant Pain; Nonunion/Delayed-union Bone Fracture
MAUDE report 20073000 ↗
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- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE Intramedullary Limb Lengthening System LSB5-040Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls0 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 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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