NA 359.204Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982197054), received between Mar 30, 2017 and Oct 31, 2024 — classified as 2 malfunctions.

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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2024

  THIS PAIR OF PLIERS BROKE WHILE ATTEMPTING TO REMOVE A NAIL FROM THE PATIENT'S LEG. THE TIP FRAGMENTED INTO MULTIPLE PIECES. ONE FRAGMENT OF THE PLIERS WAS FOUND IN THE SUCTION CANNISTER, A SECOND FRAGMENT WAS FOUND AND REMOVED FOLLOWING AN XRAY TO CHECK FOR ADDITIONAL FRAGMENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 20577341 ↗
• MalfunctionMar 30, 2017Break; Material Fragmentation; Device Operates Differently Than Expected; Break; Material Fragmentation; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE SET OF LOCKING PLIERS WILL NOT LOCK. IT WAS FURTHER EXPLAINED THAT A PIECE OF THE INSTRUMENT WAS BROKEN OFF. THE REPORTED ISSUES WERE DISCOVERED DURING ROUTINE INSPECTION. IT IS UNKNOWN WHEN THE INSTRUMENT BECAME DAMAGED. THERE WAS NO REPORT PATIENT OR SURGICAL PROCEDURE ASSOCIATED WITH THE REPORTED CONDITIONS. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6445558 ↗