GAMMA 3430-0360SRecalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540375483), received between Mar 11, 2020 and Mar 11, 2020 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- Failure of Implant1
- Injury1
- Nonunion/Delayed-union Bone Fracture1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 11, 2020Fracture; Fracture
PRIMARY SURGERY (B)(6) 2015 GAMMA LONG NAIL FOR SUBTROCHANTERIC FRACTURE OF THE FEMUR. RIGHT HIP JOINT PAIN STARTED AROUND (B)(6) 2019. THE PATIENT WAS CONSULTED ON (B)(6) 2020, AND FOUND FALSE JOINTS AND IMPLANT BREAKAGE. ON (B)(6) 2020, A BROKEN IMPLANT WAS REMOVED AND A REVISION SURGERY WAS PERFORMED USING A FEMORAL PLATE MADE BY ANOTHER COMPANY.
Patient problems: Failure of Implant; Injury; Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 9821049 ↗
Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices
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- NA 03.037.026Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES225 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls2 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-045Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- 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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