T2 2339-1036SRecalls & 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 07613327292510), received between Apr 18, 2023 and Nov 12, 2025 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Break2
- Device Damaged by Another Device1
Patient problems
- Failure of Implant2
- Implant Pain1
- Nonunion/Delayed-union Bone Fracture1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 12, 2025Fracture; Device Damaged by Another Device; Fracture; Device Damaged by Another Device
AS REPORTED: "NAIL BREAK PRIOR TO OSTEOSYNTHESIS. REPLACED WITH SYNTHES RFNA AND RIA".
Patient problems: Pain
MAUDE report 23535810 ↗InjuryOct 10, 2023Break; Fracture; Break; Fracture
AS REPORTED: "NAIL BROKE AT MOST DISTAL PROXIMAL SCREW IN ALPHA RETRO. IMPLANTED IN FEBRUARY." ACCORDING TO ADDITIONAL INFORMATION RECEIVED THE BROKEN NAIL WAS REMOVED AND A LARGER DIAMETER SCN WAS IMPLANTED. IT WAS FURTHER REPORTED SUBSEQUENTLY THAT PAIN SHOWED THAT THE NAIL HAD BROKEN IN CLINIC FOLLOW UP.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 17907115 ↗InjuryApr 18, 2023Break; Fracture; Break; Fracture
AS REPORTED: "A VOICEMAIL CAME IN TODAY FROM A T&E SALES REP FROM SAN ANTONIO, TX REGARDING THE BREAKAGE OF 3 RETROGRADE FEMUR NAILS WITHIN A 9-DAY SPAN. THIS PATIENT WAS REVISED WITH SYNTHESE NAILS. THERE WAS NON-UNION.
Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture
MAUDE report 16765725 ↗
Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices
- NA 03.033.001Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES265 reports
- 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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