T2 1806-1402Recalls & reported problems
Stryker GmbH · Nail Adapter SPI · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327005387), received between Oct 12, 2021 and Nov 10, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (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 16, 2026.
Most reported problems
Device problems
- Mechanical Jam2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 12785969 ↗MalfunctionOct 12, 2021Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT DURING A CASE USING A T2 TIBIAL NAIL THE NAIL HOLDING SCREW [PN 1806-1401] WAS JAMMED IN THE NAIL ADAPTOR [PN 1806-1402] . WE SWITCHED FROM SUPRAPATELLAR TO INFRAPATELLAR. A SECOND INCISION HAS TO BE MADE AND 20MIN DELAY IN SURGICAL TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12613890 ↗
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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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