NA 2351-0040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327361728), received between May 9, 2022 and May 9, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2022Use of Device Problem; Use of Device Problem

  AS REPORTED: "THE SURGEON INSERTED A 9MM T2 ALPHA TIBIA NAIL VIA THE SUPRAPATELLAR APPROACH. SURGEON REAMED TO 10.5, AND MEASURED 320. HE CHOSE TO USE A 300 NAIL. THE CANAL WAS NARROW AND THE SURGEON WOULD HAVE USED AN 8MM NAIL IF AVAILABLE. PROXIMAL SCREWS AND THEN DISTAL SCREWS WERE INSERTED. AFTER DISTAL SCREW INSERTION, SURGEON WAS UNABLE TO DETACH NAIL HOLDING BOLT FROM THE IM ROD. THE SURGEON SPENT ~10 MINUTES TRYING TO USE THE BALL TIP SCREW DRIVER TO DISENGAGE THE BOLT. HE WAS UNABLE TO DO SO. VICE GRIPS WERE EVENTUALLY USED TO REMOVE THE SCREW. FORCE AND COUNTER FORCE HAD TO BE USE TO DISENGAGE THE SCREW FROM THE ROD AND REMOVE THE NAIL ADAPTER / NAIL HOLDING BOLT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14341895 ↗