T2 1822-1034SRecalls & reported problems
Stryker GmbH · Tibial Nail, Standard · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540197917), received between Apr 9, 2021 and Feb 21, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (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
- Mechanical Jam3
- Device Damaged by Another Device1
- Fracture1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2026Fracture; Device Damaged by Another Device; Mechanical Jam
IT WAS REPORTED THAT A NAIL HOLDING SCREW JAMMED INTO THE NAIL HOLDING ADAPTER DURING A T2 TIBIA NAIL INSERTION. THIS WAS DURING A CASE WHEN THE NAIL WOULD NOT DE-THREAD FROM THE JIG, THIS RESULTED IN THE NAIL SNAPPING PROXIMALLY INSIDE THE PATIENT, THIS WAS REMOVED AND REPLACED WITH ANOTHER NAIL USING ANOTHER SET. NO REPORTED ADVERSE EFFECTS OTHER THAN A SIGNIFICANT TIME DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24409267 ↗MalfunctionNov 10, 2021Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT DURING IMPLANTATION OF A T2 TIBIAL NAIL USING THE SUPRAPATELLAR INSTRUMENTATION THE NAIL APPEARED TO HAVE GOTTEN FUSED TO THE NAIL HOLDING BOLT AND INSERTION ARM. THE STAFF SPENT 10-15 MINUTES ATTEMPTING TO DISENGAGE THE NAIL BUT WERE UNABLE TO. THEY ELECTED TO USE THE STANDARD APPROACH WITH A NEW NAIL. THE NAIL WAS ABLE TO BE DISENGAGED AFTER IT WAS RETURNED TO STRYKER CANADA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12786411 ↗MalfunctionApr 9, 2021Separation Failure; Mechanical Jam; Separation Failure; Mechanical Jam
THE CUSTOMER REPORTED THAT : "STRYKER TIBIA NAIL FIXATION SLEEVE STUCK IN THE TIBIA NAIL HOLDER (1806-1002 - N°KH171892) AND IN THE NAIL: IMPOSSIBLE TO UNSCREW THEM AND THEREFORE TO PLACE THE NAIL (1822-1034S - N°K03F75C) IN THE PATIENT, THEREFORE CHANGE THE SIZE OF THE NAIL AND PLACE A NAIL WITHOUT AN ANCILLARY. IN THE END, THERE IS NO CLINICAL IMPACT FOR THE PATIENT. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11641954 ↗
Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices
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- 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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