GAMMA 3325-0300SRecalls & reported problems
Stryker GmbH · Long Nail Kit R2.0, Ti, LEFT · 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 07613153313458), received between Mar 22, 2019 and Apr 29, 2022 — classified as 3 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.
Most reported problems
Device problems
- Fracture3
- Break2
Patient problems
- Failure of Implant2
- Injury1
- No Known Impact Or Consequence To Patient1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 29, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT A GAMMA NAIL BROKE AND THE PATIENT REQUIRED REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 14249928 ↗InjurySep 1, 2020Fracture; Fracture
AS REPORTED: "ON (B)(6)2020 SUDDENLY TURNING ON THE RIGHT THIGH WHEN TURNING UNDER FULL LOAD. RADIOLOGICAL BREAKAGE OF THE GAMMA NAIL BELOW THE CARRIER SCREW. CLINICALLY FATIGUE FRACTURE OF THE MATERIAL WITH INADEQUATE BONE HEALING."
Patient problems: Failure of Implant; Injury; Nonunion/Delayed-union Bone Fracture
MAUDE report 10479837 ↗InjuryMar 22, 2019Break; Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT BROKE. FURTHER INFORMATION NOT AVAILABLE AT THE MOMENT. REVISION SURGERY IS PLANNED FOR (B)(6) 2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8445002 ↗
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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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