NA 329.12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982191823), received between Apr 3, 2017 and Jan 12, 2026 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 12, 2026Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE AIMING ARM HOLES ARE STICKING TO TROCARS & PLATE BENDER IS GETTING STUCK. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045906 ↗
• MalfunctionApr 3, 2017Break; Break

  IT WAS REPORTED ON (B)(6) 2017 THAT THE HOSPITAL¿S TECHNICIAN FROM CENTRAL SERIAL PROCESSING DEPARTMENT HAD TWO (2) BROKEN INSTRUMENTS THAT CAME DOWN FROM THE OPERATING ROOM. THE BENDING PLIERS WERE BROKEN INTO TWO PIECES AT THE INSTRUMENT HINGE AND THE DEPTH GAUGE IS REPORTED AS BROKEN AT THE DISTAL TIP. NO ADDITIONAL INFORMATION WAS GIVEN FROM THE HOSPITAL, AND NOTHING ELSE IS FORTHCOMING. THERE WAS NO REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT; HOWEVER, IT IS UNKNOWN WHEN THE REPORTED DEVICE WERE BROKEN. THE REPORTED ISSUES WERE DISCOVERED DURING INSTRUMENT INSPECTION. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6453625 ↗