GAMMA 3525-0300SRecalls & 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 04546540375711), received between Nov 18, 2020 and Apr 22, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Fracture3
- Break2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure of Implant2
- Nonunion/Delayed-union Bone Fracture2
- Insufficient Information1
- Limb Fracture1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2025Break; Fracture; Break; Fracture
AS REPORTED: "THE END USER HAS REPORTED THAT A GAMMA LONG NAIL BROKE WHILE THE PATIENT WAS WALKING NORMALLY, 6 MONTHS AFTER THE SURGERY. NOW HE IS UNDERGOING INVESTIGATION PRIOR TO SURGERY TO REMOVE THE NAIL."
Patient problems: Insufficient Information; Nonunion/Delayed-union Bone Fracture
MAUDE report 21881829 ↗InjuryApr 4, 2023Break; Fracture; Break; Fracture
AS REPORTED; "THE GAMMA3 NAIL WAS IMPLANTED INTO THE LEFT THIGH ON (B)(6) 2022. ON (B)(6) 2023, FRACTURE OF THE NAIL WAS FOUND. THE REVISION SURGERY FOR REPLACING THE FRACTURED NAIL IS SCHEDULED ON (B)(6) 2023."
Patient problems: Failure of Implant
MAUDE report 16678164 ↗InjuryJan 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "A PATIENT WHO HAD UNDERGONE SURGERY ABOUT A YEAR AND A HALF AGO WAS RE-OPERATED ON AFTER A POSTOPERATIVE PSEUDOARTHROSIS WAS IDENTIFIED."
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 13236661 ↗InjuryNov 18, 2020Fracture; Fracture
AS REPORTED: "TROCHANTERIC FRACTURE OF THE FEMUR. THE PATIENT WALKED AFTER THE OPERATION AND RE-FRACTURED. THE NAIL WAS DAMAGED."
Patient problems: Failure of Implant; Limb Fracture
MAUDE report 10864372 ↗
Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices
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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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