GAMMA 3425-1320SRecalls & reported problems
Stryker GmbH · Long Nail Kit R1.5, Ti, RIGHT · 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 07613252273813), received between Jul 20, 2021 and Sep 25, 2023 — classified as 4 injuries.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
- Break3
Patient problems
- Failure of Implant4
- Fall1
- Implant Pain1
- 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.
InjurySep 25, 2023Break; Fracture; Break; Fracture
AS REPORTED: "FRACTURE OF THE IMPLANT IN THE CASE OF A DOMESTIC FALL EVENT THAT CANNOT BE RULED OUT. PATIENT HAD REVISION SURGERY THE NEXT DAY.
Patient problems: Failure of Implant; Fall
MAUDE report 17813871 ↗InjuryAug 25, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE PATIENT'S RIGHT FEMUR WAS REVISED DUE TO NON-UNION OF A FEMORAL NECK FRACTURE. PRE-OP X-RAYS ALSO SHOWED A BROKEN DISTAL SCREW. INTRA-OPERATIVELY, THE NAIL WAS FOUND TO BE BROKEN WHERE THE LAG SCREW PASSES THROUGH THE NAIL. PATIENT WAS REVISED TO A HEMI HIP CONSTRUCT INCLUDING A RESTORATION MODULAR STEM CONSTRUCT.
Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture
MAUDE report 17625249 ↗InjuryDec 20, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT AFTER A PATIENT CAME IN COMPLAINING OF PAIN, A X-RAY WAS TAKEN AND A FRACTURE OF THE IMPLANT WAS DETECTED ON (B)(6) 2022. THE REVISION SURGERY TOOK PLACE ON(B)(6) 2022.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 16013859 ↗InjuryJul 20, 2021Fracture; Fracture
THE CUSTOMER INFORMED STRYKER THAT ON JUNE 24, DURING THE ME OF A GAMMA3 11MM 320 125-DEGREE NAIL ON THE RIGHT, THE NAIL BROKE IN THE IS BROKEN IN THE UPPER AREA.
Patient problems: Failure of Implant
MAUDE report 12196441 ↗
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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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