T2 2339-1136SRecalls & reported problems
Stryker GmbH · Class 2 · Implant
Data updated Oct 18, 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 07613327293593), received between Mar 2, 2023 and Nov 5, 2025 — classified as 3 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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Break1
- Device Dislodged or Dislocated1
Patient problems
- Nonunion/Delayed-union Bone Fracture2
- Failure of Implant1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 5, 2025Fracture; Fracture
AS REPORTED: "DISTAL FEMUR ORIF PERFORMED WITH SINGLE CONSTRUCT T2 ALPHA RETROGRADE NAIL AND INTERLOCKING 5MM SCREWS AND A BLOCKING SCREW NEAR THE BREAK SITE. AN OBLIQUE INTERLOCKING SCREW WAS REMOVED DUE TO BACKOUT PROMINENCE AND THEN AT A LATER DATE THE NAIL WENT ON TO BREAKAGE AT THE 6TH HOLE OF THE DISTAL CLUSTER OF INTERLOCKING SCREWS. THE SURGEON AND RESIDENTS REMOVED THE NAIL AND PERFORMED A RIA AND NAIL REPLACEMENT USING THE SYNTHES RFNA RETROGRADE FEMUR NAILING SYSTEM ADVANCED.
Patient problems: Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 23478005 ↗InjuryMay 29, 2024Break; Fracture; Break; Fracture
IT WAS REPORTED: "AN ALPHA RETROGRADE NAIL BROKE THROUGH THE MIDDLE OF THE MOST DISTAL STATIC OPTION HOLE (ABOVE THE OBLONG DYNAMIC HOLE). APPROXIMATELY 2 MONTHS AFTER IMPLANTATION. PATIENT WAS WEIGHT BEARING AND WALKING; DID NOT EXPERIENCE A FALL".
Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture
MAUDE report 19420718 ↗InjuryMar 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS BROUGHT BACK TO REVISE AN INTERLOCKING SCREW THAT WAS BACKING OUT AND TAKE OUT ANTIBIOTIC SPACER. MINIFRAG AND SMALL FRAG PLATING, ALONG WITH BONE GRAFTING WERE USED DURING THE REVISION.
Patient problems: Insufficient Information
MAUDE report 16466515 ↗
Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices
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- GAMMA 3125-1180SStryker GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES249 reports
- NA 03.037.026Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES225 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls2 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-045Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE Intramedullary Limb Lengthening System LSB5-040Nuvasive 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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