NA 391.967Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587041056), received between Aug 13, 2018 and Aug 13, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLES OF (2) SHORT-CUT PLATE CUTTERS BROKE. IT IS UNKNOWN IF THERE WAS A SURGICAL PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SHORTCUT PLATE CUTTER FOR 2.4MM PLATES & THORP. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7777895 ↗
• MalfunctionAug 13, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLES OF (2) SHORT-CUT PLATE CUTTERS BROKE. IT IS UNKNOWN IF THERE WAS A SURGICAL PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SHORTCUT PLATE CUTTER FOR 2.4MM PLATES & THORP. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7777894 ↗