NA 312.401Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982187741), received between Dec 13, 2016 and Dec 13, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 13, 2016Break; Break

  IT WAS REPORTED THAT DURING A DISTAL TIBIA FRACTURE PROCEDURE, AS THE SURGEON WAS BEGINNING TO DRILL FOR THE SCREW HOLE, A DRILL GUIDE BROKE AT THE WELD JOINT. THERE WERE NO SMALL FRAGMENTS GENERATED; THE TWO LARGE, BROKEN PIECES WERE EASILY RETRIEVED WITHOUT ANY MEDICAL INTERVENTION BEING REQUIRED. THERE WAS ANOTHER DRILL GUIDE READILY AVAILABLE TO SUCCESSFULLY COMPLETE THE SURGERY. THERE WAS NO SURGICAL DELAY, NO ADDITIONAL MEDICAL INTERVENTION REQUIRED AND NO REPORTED HARM TO THE PATIENT. THERE WERE NO UNANTICIPATED X-RAYS REQUIRED DURING THE SURGERY. THE PATIENT WAS REPORTED TO BE STABLE AT THE END OF THE SURGERY. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6171998 ↗