NA 391.82Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982198310), received between Mar 14, 2017 and Apr 3, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SAW ATTACHMENT TEETH WAS BROKEN. NO PATIENT INVOLVED AND NO PATIENT CONSEQUENCES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767074 ↗
• MalfunctionJan 8, 2025Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT ON DECEMBER 19, 2024 THE SCREWDRIVER PITTING ALONG SHAFT. THE INSTRUMENTS WERE BENDING AS WELL. IT WAS ALSO REPORTED THAT THEY WERE CHIPPED AND LOOSE. THERE WAS NO OPERATION INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102052 ↗
• MalfunctionApr 27, 2017Break; Break

  (B)(4) REPORTED THAT A PAIR OF WIRE BENDING PLIERS WERE NOTED BY INSTRUMENT ROOM STAFF TO HAVE A SHARP EDGE ON THE DEVICE. IT IS UNKNOWN IF THE DEVICE WAS USED IN OR IMPACTED A SURGICAL PROCEDURE PRIOR TO THE MALFUNCTION BEING NOTED. THERE WERE NO ADVERSE EVENTS REPORTED DUE TO THE USE OF THIS DEVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THIS IS REPORT NUMBER 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6527146 ↗
• MalfunctionMar 14, 2017Break; Break

  IT WAS REPORTED THAT TWO (2) WIRE-BENDING PLIERS ARE BROKEN. THE CONDITIONS WERE DISCOVERED WHILE RESTOCKING THE TRAY. BOTH DEVICES ARE BROKEN ON THE OUTER EDGE OF THE MOUTH OF THE PLIERS. IN ADDITION TO BEING BROKEN, THE CUTTING EDGE ON ONE OF THE PLIERS IS DEFORMED. THERE WERE NO REPORTED ISSUES WITH THE DEVICES PRIOR TO DISCOVERY. THERE IS NO REPORTED PATIENT OR SURGICAL INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THIS REPORT IS 2 OF 2 FOR COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6404988 ↗
• MalfunctionMar 14, 2017Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT TWO (2) WIRE-BENDING PLIERS ARE BROKEN. THE CONDITIONS WERE DISCOVERED WHILE RESTOCKING THE TRAY. BOTH DEVICES ARE BROKEN ON THE OUTER EDGE OF THE MOUTH OF THE PLIERS. IN ADDITION TO BEING BROKEN, THE CUTTING EDGE ON ONE OF THE PLIERS IS DEFORMED. THERE WERE NO REPORTED ISSUES WITH THE DEVICES PRIOR TO DISCOVERY. THERE IS NO REPORTED PATIENT OR SURGICAL INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6404981 ↗