GAMMA 3430-1380SRecalls & reported problems
Stryker GmbH · Long Nail Kit R1.5, Ti, RIGHT · Class 2 · Implant
All models of GAMMA (249)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252273998), received between Nov 7, 2021 and Feb 16, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture2
- Break1
Patient problems
- Failure of Implant2
- Implant Pain1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 16, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT A GAMMA NAIL WAS BEING IMPLANTED AND BROKE. "WAS A SUBTROCH FRACTURE NAILED IMPLANT FRACTURE AT 2 MONTHS; REVISED TO A PROXIMAL FEMORAL REPLACEMENT."
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 13546463 ↗InjuryNov 7, 2021Fracture; Fracture
IT WAS REPORTED THE PATIENT HAD A BROKEN NAIL. THEY PRESENTED WITH PAIN. REVISION SURGERY WAS REQUIRED.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 12759446 ↗
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- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE Intramedullary Limb Lengthening System LSB5-075Nuvasive 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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