GAMMA 3420-0320SRecalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540375209), received between Sep 16, 2022 and May 29, 2026 — classified as 3 injuries.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure of Implant2
- Nonunion/Delayed-union Bone Fracture2
- Fall1
- Limb Fracture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem
AS REPORTED: "ON (B)(6) 2025, THE DEVICE WAS IMPLANTED TO RIGHT FEMUR OF THE PATIENT. REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2026 DUE TO NONUNION."
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 25339499 ↗InjuryJul 18, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT POSTOPERATIVELY THE NAIL BROKE OFF AT THE LAG SCREW HOLE DUE TO A FALL, LEADING TO A RE-FRACTURE AND REVISION SURGERY.
Patient problems: Failure of Implant; Fall; Limb Fracture
MAUDE report 17347352 ↗InjurySep 16, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT PRIMARY SURGERY FOR A TROCHANTERIC FRACTURE WAS PERFORMED ON (B)(6) 2021. ON AN UNKNOWN DATE, ONE DISTAL SCREW WAS REMOVED DUE TO POSTOPERATIVE PSEUDARTHROSIS AND DYNAMIZATION WAS ATTEMPTED, BUT THERE WAS NO BONY FUSION AND THE NAIL AND DISTAL SCREW BROKE OFF. REVISION SURGERY TO THA WAS PERFORMED ON (B)(6) 2022.
Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture
MAUDE report 15439808 ↗
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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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