NA 391.906Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982198402), received between Jul 28, 2021 and Oct 25, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2024Break; Break

  IT WAS REPORTED THAT THE CUTTER EDGE IS BROKEN. IT HAPPENED DURING CUTTING A CERCLAGE WIRE IN AN OPERATION. SIMILAR PRODUCT WAS USED TO PRECEDE WITH PROCEDURE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 20533513 ↗
• MalfunctionMar 28, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 13-MARCH-2024, A LIGHT BLUE STICKY STAIN WAS DISCOVERED ON THE CABLE CUTTER IN QUESTION. THE PRODUCT WAS SHIPPED TO THE HOSPITAL PRIOR TO THE SURGERY SCHEDULED FOR (B)(6) 2024. THE PRODUCT WAS STILL PLANNED FOR USE DURING THE PROCEDURE BECAUSE THE STAIN WAS ABLE TO BE REMOVED AFTER WASHING. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CABLE CUTTER-LARGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18990488 ↗
• MalfunctionMar 4, 2024Break; Break

  IT WAS REPORTED THAT CABLE CUTTER BROKE. THERE WAS NO PATIENT WAS INVOLVED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1). THIS IS REPORT 1 OF 1 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827142 ↗
• MalfunctionOct 27, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON OCTOBER 6, 2023, THERE WAS PITTING ON THE CUTTER. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE CABLE CUTTER-LARGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18019708 ↗
• MalfunctionJun 23, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CABLE CUTTER LRG FOUND IN TRAY BROKEN. IT WAS UNKNOWN WHEN WAS THE EVENT OCCURRED. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE CABLE CUTTER LRG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14787600 ↗
• MalfunctionFeb 8, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN INSPECTION, THE CABLE TENSIONER WAS DISCOVERED AS DEFECTIVE. NO SPECIFIC ISSUE WAS IDENTIFIED. NO SURGICAL IMPACT. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CABLE CUTTER-LARGE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13483079 ↗
• MalfunctionJan 5, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING LOAN KIT INSPECTION IT WAS FOUND THAT THE PART OF ONE OF THE CUTTING JAWS OF THE CABLE CUTTER HAS BROKEN OFF. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR (1) CABLE CUTTER-LARGE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13172609 ↗
• MalfunctionJul 28, 2021Break; Break

  IT WAS REPORTED THAT DURING THE DEVICE WAS WASHED, IT WAS FOUND OUT THAT CABLE CUTTER HAS A BROKEN GEAR. THERE WAS NO PATIENT INVOLVEMENT, NO SURGICAL DELAY. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) CABLE CUTTER-LARGE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12240398 ↗