NA 391.965Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587041032), received between Mar 8, 2017 and Apr 21, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020, DURING CLEANING OF THE SETS. THREE (3) INSTRUMENTS FROM THE HOSPITAL WERE OBSERVED TO HAVE BROKEN. THE DEVICES INVOLVED WERE THE PLATE HOLDING FORCEPS WHICH LOCKING MECHANISM BROKE AND CANNOT LOCK, THE SCREWDRIVER HANDLE WITH HEX COUPLING BROKE IN HALF AND THE COMBINATION BENDING/CUTTING PLIERS TIPS ARE BROKEN OFF. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) COMBINATION BENDING/CUTTING PLIERS F/1.0MM - 2.0MM PLATES. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9980756 ↗
• MalfunctionJul 17, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE COMBINATION BENDING/CUTTING PLIERS PRONG THAT PUSHES AGAINST BOTH GRIP HANDLES IS SNAPPED OFF. THIS WAS NOT USED DURING THE CASE BUT JUST RECOGNIZED DURING PRE-OP. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) COMBINATION BENDING/CUTTING PLIERS F/1.0 MM - 2.0 MM PLATES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8800037 ↗
• MalfunctionMar 8, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A MID-FACE ORBITAL FLOOR BLOWOUT PROCEDURE ON (B)(6) 2017, WHILE THE SURGEON WAS BENDING THE PLATE ON THE BACK-TABLE, THE TENSION SPRING BROKE NEAR THE MAIN FRAME OF THE COMBINATION BENDING/CUTTING PLIERS AND FELL OUT. THE SURGEON EASILY RETRIEVED THE SPRING. SINCE THIS EVENT OCCURRED AT THE BACK TABLE, THE SPRING DID NOT FALL INTO THE PATIENT¿S WOUND. THE SURGEON FINISHED THE PROCEDURE WITH A READILY AVAILABLE BACK-UP DEVICE. THERE WAS NO SURGICAL TIME DELAY OR HARM TO THE PATIENT. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN PLATE - PART# - UNKNOWN, LOT# - UNKNOWN, QUANTITY# - 1. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6390210 ↗