GAMMA 3525-3360SRecalls & reported problems
Stryker GmbH · Long Nail Kit R1.5, Ti, LEFT · Class 2 · Implant
All models of GAMMA (249)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540409911), received between Apr 2, 2019 and May 29, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Fracture3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure of Implant3
- Implant Pain1
- No Known Impact Or Consequence To Patient1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2024Break; Fracture; Break; Fracture
AS REPORTED: "GAMMA3 NAIL FRACTURE AT THE LEVEL OF THE FEMORAL NECK SCREW. THE PATIENT REQUIRED REVISION."
Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture
MAUDE report 19419997 ↗InjuryApr 20, 2023Break; Fracture; Break; Fracture
AS REPORTED: "REVISION NOT YET OCCURRED - BROKEN GAMMA NAIL TO BE REMOVED."
Patient problems: Failure of Implant
MAUDE report 16779441 ↗InjuryMay 20, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT A PATIENT GOT PAIN, X-RAY SHOWED BROKEN NAIL, THE NAIL WAS REMOVED AND A NEW GAMMA3 NAIL WAS INSERTED.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 14458913 ↗InjuryApr 2, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE LEFT GAMMA NAIL 13X360 WAS EXPLANTED AND RIGHT GAMMA NAIL 13X360 WAS IMPLANTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8474785 ↗
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
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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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