GAMMA 3430-0260SRecalls & reported problems
Stryker GmbH · Long Nail Kit R1.5, Ti, RIGHT · Class 2 · Implant
All models of GAMMA (249)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540375438), received between May 7, 2019 and Mar 20, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Most reported problems
Device problems
- Fracture2
- Break1
Patient problems
- Failure of Implant1
- Injury1
- Nonunion/Delayed-union Bone Fracture1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2020Fracture; Fracture
AS REPORTED: "AFTER SURGERY OF FRACTURE OF FEMUR WITH GAMMA 3 NAIL, THE PATIENT EXPERIENCED FALSE JOINT AND BREAKAGE OF THE NAIL."
Patient problems: Failure of Implant; Injury; Nonunion/Delayed-union Bone Fracture
MAUDE report 9862955 ↗InjuryMay 7, 2019Break; Fracture; Fracture
IT WAS REPORTED THAT PATIENT FELT PAIN ON (B)(6) 2019. THE PAIN INTENSIFIED ON (B)(6) 2019 FOUR DAYS LATER AND THE PATIENT VISITED THE HOSPITAL. X-RAY CONFIRMED THAT THE NAIL WAS BROKEN. (B)(6) 2019 REVISION SURGERY WAS PERFORMED.
Patient problems: Pain
MAUDE report 8588487 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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