NA 03.130.271Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982075475), received between May 31, 2019 and Jul 9, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT PLATE CUTTER BROKE INTRAOPERATIVELY DURING AN ORIF HAND PROCEDURE ON AN UNKNOWN DATE. NO FRAGMENTS WERE GENERATED. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461447 ↗
• MalfunctionMar 6, 2025Break; Break

  IT WAS REPORTED THAT BEFORE A HAND SURGERY, THE VA HANDSET WAS USED AND THE PLATE CUTTER DEVICE WAS NOT USABLE. THE PLASTIC PIECE ON THE HEAD OF THE PLATE CUTTER WAS BROKEN/ FELL OFF. THERE WAS NO PATIENT INVOLVEMENT OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536102 ↗
• MalfunctionFeb 15, 2024Failure to Cut; Device-Device Incompatibility; Material Deformation; Failure to Cut; Device-Device Incompatibility; Material Deformation

  IT WAS ADDITIONALLY REPORTED THE PLATE CUTTING HANDLE HAS BEEN BENT OUTSIDE OF ITS INTENDED SHAPE AND IS NO LONGER PROVIDING CLEAN CUTS TO INTENDED PLATES. IT IS VERY DIFFICULT TO UTILIZE AND NOT WORKING THE WAY IT WAS INITIALLY INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711109 ↗
• MalfunctionFeb 13, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS FURTHER REPORTED THE PLATE CUTTING HANDLE HAS BEEN BENT OUTSIDE OF ITS INTENDED SHAPE AND IS NO LONGER PROVIDING CLEAN CUTS TO INTENDED PLATES. IT IS VERY DIFFICULT TO UTILIZE AND NOT WORKING THE WAY IT WAS INITIALLY INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18694094 ↗
• MalfunctionDec 8, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON OCTOBER 12, 2023, A PLATE CUTTER AND AN NAIL EXTRACTOR WERE DULL AND WOULD NOT CUT. UPON MANUFACTURER INSPECTION, IT WAS DETERMINED THAT THE PLATE CUTTER LOWER JAW WAS BENT, CAUSING IT TO NOT CUT CORRECTLY. THIS REPORT IS FOR A PLATE CUTTER FOR 1.3MM/1.5MM AND 2.0MM PLATES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18293408 ↗
• MalfunctionJul 20, 2023Break; Break

  IT WAS REPORTED THAT ON JUNE 28, 2023, IT WAS NOTICED UPON INSPECTION THAT THE PLIERS WON¿T CUT ANYMORE. THE DEVICE WAS BROKEN. THERE WAS NO PATIENT OR OPERATION INVOLVEMENT. THIS REPORT INVOLVES ONE PLATE CUTTER FOR 1.3MM/1.5MM AND 2.0MM PLATES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17360723 ↗
• MalfunctionAug 29, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE¿S A PIECE OF METAL THAT SEEMS TO BE STUCK IN THE CUTTING PORTION OF THE PLATE CUTTER. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PLATE CUTTER FOR 1.3/1.5 AND 2.0 PLATES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15312079 ↗
• MalfunctionMay 25, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, A PLATE CUTTER FOR 1.3MM/1.5MM AND 2.0MM PLATES WAS OBSERVED DAMAGED. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES 1 DEVICE. THIS IS REPORT 1 OF 1 FOR PC (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10085659 ↗
• MalfunctionMay 14, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT DPY LYNDHURST UPS FSL, IT WAS OBSERVED THAT THE PLATE CUTTER WAS DAMAGED AND BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES 1 DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10057734 ↗
• MalfunctionApr 15, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, THE PLATE CUTTER WAS OBSERVED DAMAGED. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9961837 ↗
• MalfunctionMar 16, 2020Break; Break

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE PLATE CUTTER WAS DAMAGED. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE WAS BROKEN. THIS REPORT IS FOR A PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9836651 ↗
• MalfunctionOct 8, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED AN UNKNOWN DATE THAT SILICON INSERTS HAVE COME AWAY FROM CUTT-PLIERS F/LOCK PL 1.3+VA LOCK PL 1.5. THE PATIENT CONSEQUENCES IS UNKNOWN. THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9167913 ↗
• MalfunctionMay 31, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A ROUTINE INCOMING INSPECTION, IT WAS OBSERVED THAT THE PLATE CUTTER WAS MISSING A PIECE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PLATE CUTTER FOR 1.3 MM/1.5 MM AND 2.0 MM PLATES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8658955 ↗
• MalfunctionMay 31, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING ROUTINE INCOMING INSPECTION, IT WAS OBSERVED THAT THE PLATE CUTTER WAS MISSING A PIECE. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) PLATE CUTTER FOR 1.3 MM/1.5 MM AND 2.0 MM PLATES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8658900 ↗
• MalfunctionMay 31, 2019Break; Break

  IT WAS REPORTED THAT ON APRIL 17, 2019, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, A PLATE CUTTER WAS MISSING A PIECE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PLATE CUTTER FOR 1.3 MM/1.5 MM AND 2.0 MM PLATES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8658867 ↗