EXPEDIUM 299704185Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034467177), received between Nov 27, 2023 and Apr 20, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 20, 2026Material Deformation

  IT WAS REPORTED THAT BENDER WAS DAMAGED, METAL BENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927933 ↗
• MalfunctionApr 20, 2026Material Deformation

  IT WAS REPORTED THAT POLY SHAFT DRIVERS ARE STRIPPED. THE HANDLES ARE NOT RATCHING. THE TAPS ARE DULL AND THE BENDERS ARE DAMAGED, METAL BENT. ROD HOLDERS WORN. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925175 ↗
• MalfunctionApr 14, 2026Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT POLY SHAFT DRIVERS STRIPPED. HANDLES NOT RATCHING. TAPS DULL. BENDERS DAMAGED, METAL BENT. ROD HOLDERS WORN. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24870983 ↗
• MalfunctionApr 14, 2026Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT POLY SHAFT DRIVERS STRIPPED. HANDLES NOT RATCHING. TAPS DULL. BENDERS DAMAGED, METAL BENT. ROD HOLDERS WORN. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24870972 ↗
• MalfunctionNov 11, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT PRODUCTS ARE BENT DUE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523886 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT THE FRENCH BENDER CENTER PORTION BROKEN. CORONAL BENDERS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892929 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT THE FRENCH BENDER CENTER PORTION BROKEN. CORONAL BENDERS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891786 ↗
• MalfunctionNov 27, 2023Break; Corroded; Break; Corroded

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT AFTER SURGERY, THE STERILE DEPARTMENT FOUND SIGNS OF SMALL ¿HOLES¿ AND RUST ON THE SURFACE OF THE INSTRUMENTS. THE INSTRUMENTS ARE RARELY USED. IT LOOKS LIKE A ¿NON-MECHANICAL¿ REASON OF THE SURFACE CHANGES. INSTRUMENTS AND DECONTAMINATION CERTIFICATION WILL BE PICKED UP NEXT WEEK AT CLINIC. SAME LIKE PRODUCT WAS USED TO MANAGE THE PROBLEM. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CORONAL IN-SITU BENDER, LEFT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211818 ↗