NA 391.962Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10886982198525), received between Jan 27, 2017 and Mar 23, 2026 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Break” (32 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THERE WERE BROKEN BENDERS, MISSING SCREWS/PLATES FROM VOLT MINI HAVING INADEQUATE STORAGE, AND THE TROCAR/HAMMER CRACKED/TWISTED OFF FROM HINDFOOT NAIL. IT IS UNKNOWN WHEN THE EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663860 ↗
• MalfunctionOct 8, 2025Break; Break

  IT WAS REPORTED THAT THE CUTTING SLOT OF THE PLIERS ARE BROKEN. A SMALL PIECE FELL OFF. A REPLACEMENT CUTTER WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23248429 ↗
• MalfunctionAug 14, 2025Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT ON JULY 30, 2025, THERE WAS PITTING, SCORING, CHIPPING ON DEVICES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803241 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT THE CHUNK WAS MISSING FROM TIP OF DEVICE. THERE WAS NO OPERATION INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21902613 ↗
• MalfunctionOct 17, 2024Difficult to Open or Close; Mechanical Jam; Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2024 THE PLIERS DO NOT OPEN AND CLOSE PROPERLY ANYMORE. THEY ARE JAMMED. NO SURGICAL DELAY. PROCEDURE COMPLETED SUCCESSFULLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471762 ↗
• MalfunctionOct 15, 2024Break; Break

  IT WAS REPORTED THAT THE HOSPITAL RECEIVED THE DEVICE WITH A BROKEN CARBIDE TIP AND IS UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20451842 ↗
• MalfunctionJun 6, 2024Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT ON (B)(6) 2024 THE CUTTING BLADES BROKEN, DEVICE IS ALSO PITTING AND RUSTING. THERE WAS NO PATIENT AND OPERATION INVOLVED. THIS REPORT INVOLVES ONE (1) BENDING/CUTTING PLIERS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476786 ↗
• MalfunctionMar 21, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE BENDING/CUTTING PLIERS WAS BROKE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) BENDING/CUTTING PLIERS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18953123 ↗
• MalfunctionFeb 22, 2024Break; Break

  IT WAS FURTHER NOTED THE ISSUE WAS DISCOVERED DURING INSPECTION. THE FACILITY IS A VETERINARY HOSPITAL SO THERE WAS NO HUMAN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18761402 ↗
• MalfunctionJun 29, 2023Break; Failure to Cut; Break; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE TIP OF THE INSTRUMENT WAS SLIGHTLY BROKEN. THE CUTTER WOULDN'T CUT, IT JUST BENT THEM. THERE WAS NO DELAY IN SURGERY, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THERE WERE NO BROKEN FRAGMENTS RETAINED IN THE PATIENT¿S BODY. THIS REPORT INVOLVES ONE BENDING/CUTTING PLIERS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17223950 ↗
• MalfunctionAug 5, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PLIERS IN QUESTION WERE RECEIVED BY THE STERILE PROCESSING DEPARTMENT WITH A BROKEN CARBON FIBER INSERT (IN THE PLIERS PORTION OF THE TIP). IT IS UNKNOWN HOW OR WHEN THIS ITEM WAS BROKEN). THERE WAS NO REPORTED PATIENT INTERACTION. THIS REPORT IS FOR BENDING/CUTTING PLIERS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15178542 ↗
• MalfunctionJun 27, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, THE SALES REP NOTICED THAT THERE WERE SOME THAT WERE DAMAGED AND NEEDED TO BE REPLACED. BENDING PLIERS FOR 2.7MM & 3.5MM PLATES'S BENDING EDGE WAS BENT. THIS REPORT IS FOR ONE (1) BENDING/CUTTING PLIERS. THIS IS REPORT 4 OF 5 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14836027 ↗
• MalfunctionMay 25, 2022Break; Break

  IT WAS REPORTED ON (B)(6) 2022, THE BENDING/CUTTING PLIER DEVICE WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) BENDING/CUTTING PLIER DEVICE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14497870 ↗
• MalfunctionJul 22, 2021Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE CUTTING BLADE FELL OUT OF THE CUTTING BENDING PLIERS. THIS REPORT IS FOR A CUTTING BENDING PLIERS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12212164 ↗
• MalfunctionMay 28, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING AN INSPECTION, IT WAS DISCOVERED THAT THE SCREWDRIVER HAS TWISTED TIP, PLIERS HAS BENT CUTTING EDGES, AND ADAPTOR HAS DEFORMED QUICK CONNECT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) BENDING/CUTTING PLIERS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904380 ↗
• MalfunctionMay 5, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE CARBIDE CUTTING/BENDING PLIERS WERE REPORTED TO HAVE THE CARBIDE CHIPPED OFF. THERE WAS NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) BENDING/CUTTING PLIERS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11777433 ↗
• MalfunctionFeb 11, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 IN THE INSPECTION TIME IT WAS DISCOVERED THAT THE POINTED TOOTH OF PLIER HAS CHIPPED OFF. THERE WAS NO SURGERY AND PATIENT INVOLVEMENT REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) UNK - PLATES. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11315777 ↗
• MalfunctionFeb 5, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BENDING/ CUTTING PLIERS ARE STICKING AND TIP IS BROKEN. IT IS UNKNOWN WHEN WAS THE ISSUE DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. CONCOMITANT PRODUCT REPORTED: BENDING/CUTTING PLIERS: (PART #391.962-US, LOT #A7QA47, QTY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11285882 ↗
• MalfunctionJan 21, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING INSPECTION, THE BENDING/CUTTING PLIERS WERE FOUND TO BE BROKEN. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. UPDATED EVENT DESCRIPTION: CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) BENDING/CUTTING PLIERS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11208215 ↗
• MalfunctionDec 28, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED ON (B)(6) 2020, DURING AN INSPECTION, IT WAS FOUND THAT THE BENDING/CUTTING PLIERS FAILED TO CUT THE MAXFRAME WIRE. THERE WAS NO PATIENT INVOLVEMENT. DURING INVESTIGATION OF THE RETURNED DEVICE BY THE MANUFACTURER, IT WAS NOTED THE CARBIDE INSERT BROKEN OFF AT THE CUTTING SLOT OF THE DEVICE AND A RESISTANCE WAS OBSERVED IN OPENING /CLOSING DUE TO FRICTION. CONCOMITANT DEVICE REPORTED: MAXFRAME WIRE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A BENDING/CUTTING PLIERS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077999 ↗
• MalfunctionDec 8, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BENDING/ CUTTING PLIERS HAVE BROKEN CUTTING SURFACE ON PLATE CUTTING SIDE. IT WAS DISCOVERED BY EQUIPMENT COORDINATOR DURING SET ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) BENDING/CUTTING PLIERS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10967628 ↗
• MalfunctionNov 20, 2020Break; Break

  IT WAS REPORTED THAT THE BENDING/CUTTING PLIERS WERE FOUND IN THE CENTRAL PROCESSING DEPARTMENT DAMAGED. ONE OF THE CARBON FIBER PIECES IN THE CUTTING PORTION OF THE PLIERS IS MISSING. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) BENDING/CUTTING PLIERS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10880013 ↗
• MalfunctionSep 8, 2020Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE BENDING/ CUTTING PLIERS FAILED TO OPEN AND CUT AN UNKNOWN MINI FRAGMENT PLATE. AS PER THE REPORTER, THERE WAS A MISSING TOOTH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVE UNKNOWN CUTTING DEVICE. THERE WAS NO SURGICAL DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN MINI FRAGMENT PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) BENDING/CUTTING PLIERS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10502008 ↗
• MalfunctionJun 12, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INSPECTION, IT WAS NOTICED THAT THE CUTTING PORTION OF THE BENDING CUTTING PLIERS INSERT BROKE OFF AND WILL NO LONGER CUT. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) BENDING/CUTTING PLIERS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10149058 ↗
• MalfunctionJun 1, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BENDING CUTTING PLIERS WAS BROKEN. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10106560 ↗