GAMMA 3525-3400SRecalls & 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 04546540409935), received between Jun 4, 2018 and Dec 18, 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
- Fracture2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure of Implant2
- Bone Fracture(s)1
- Implant Pain1
- Injury1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 18, 2024Break; Fracture; Break; Fracture
AS REPORTED: "GAMMA NAIL BROKE AT LAG SCREW JUNCTION". ADDITIONAL INFORMATION RECEIVED: PATIENT UNDERWENT REVISION SURGERY (B)(6) 2024, EXCHANGED BROKEN NAIL WITH SMITH & NEPHEW 13X400MM INTERTAN NAIL.
Patient problems: Failure of Implant
MAUDE report 20972613 ↗InjurySep 12, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE PATIENT HAD A GAMMA3 OPERATION ABOUT 1 1/2 YEAR AGO. NOW THE NAIL IS BROKEN. THE NAIL HAS NOW BEEN REMOVED AT A T2 ALPHA RECON WERE INSERTED (B)(6) 2022.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 15402373 ↗InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "SALES BRANCH PROVIDED PRIMARY AND REVISION USAGE SHEETS OUTLINING A PATIENT BEING CONVERTED FROM A GAMMA LONG NAIL TO A LEFT THA INCLUDING A RESTORATION MODULAR STEM CONSTRUCT. A NOTE ON THE REVISION USAGE SHEET APPEARS TO SAY "REVISED (POSSIBLY REMOVED OR REMOVAL) GAMMA LONG (NAIL)." ADDITIONAL INFORMATION RECEIVED FROM SALES REP. "PATIENT'S BONE COLLAPSED. THE NAIL STAYED IN PLACE AS THE BONE FAILED."
Patient problems: Bone Fracture(s); Injury
MAUDE report 10505238 ↗InjuryJun 4, 2018Break
GAMMA NAIL WAS REMOVED. THE NAIL WAS IN TWO PIECES SEPARATED BELOW AND ABOVE THE LAG SCREW. IT WAS REPLACED WITH A RECON NAIL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7567237 ↗
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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
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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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