NA 393.78Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982199447), received between Sep 1, 2023 and Sep 1, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionSep 1, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN EVENT OCCURRED WHERE SUPRAPATELLAR TIBIAL NAILING WAS DONE. DURING INSERTION AND DISTAL INTERLOCKING THE NAIL, THE NAIL WAS BACKSLAPPED. SURGEON BACK SLAPPED FRACTURE MALREDUCED AND ROTATED THE INSERTION HANDLE. WHILE ROTATING THE INSERTION HANDLE, THE CONNECTION TO THE NAIL LOOSENED. SURGEON WANTED THE CONNECTING SCREW AND INSERTION HANDLE TO BE REPLACED. DEPTH GAUGE WAS ALSO BENT. BLUE HANDLE DID NOT CONNECT TO POWER FOR SOME REASON. THERE WAS 5 MINUTES SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1)DEPTH GAUGE FOR LARGE EXTERNAL FIXATOR THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671135 ↗