EXCEL TRI-LOCK 2001-80-504Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295080176), received between Feb 12, 2019 and Mar 12, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED THAT THE BROACH HANDLE ATTACHMENT AND TRIAL EXTRACTOR BROKE DURING CLEANING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21588024 ↗
• MalfunctionJun 8, 2022Break; Break

  BROACH HANDLE BOLT BROKE. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14633511 ↗
• MalfunctionFeb 1, 2021Break; Break

  IT WAS REPORTED THAT AML BROACH HANDLE WAS BROKE ON THE END THAT GRABS THE BROACH AND WOULD NOT ATTACH TO BROACH. SNAPPED THE END OF IT OFF IN ONE PIECE. DELAYED THE CASE BY APPROXIMATELY 10 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 11262138 ↗
• MalfunctionJan 13, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE EXCEL BROACH DID NOT FULLY ENGAGE WITH HANDLE. THE HANDLE APPEARED TO BE WORN WHERE IT MEETS THE BROACH. IT WAS NOT USED IN SURGERY, AND SURGERY TIME WAS NOT EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11165499 ↗
• MalfunctionDec 4, 2020Structural Problem; Structural Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE BROACH DID NOT OPEN OR CLOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10943979 ↗
• MalfunctionJan 28, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH HANDLE WOULD NOT ENGAGE IN SUMMIT BROACH. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9637785 ↗
• MalfunctionOct 24, 2019Unintended Movement; Unintended Movement

  TIGHTEN SPRING MECHANISM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9235854 ↗
• MalfunctionOct 24, 2019Unintended Movement; Unintended Movement

  TIGHTEN SPRING MECHANISM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9235853 ↗
• MalfunctionOct 24, 2019Unintended Movement; Unintended Movement

  TIGHTEN SPRING MECHANISM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9235845 ↗
• MalfunctionFeb 12, 2019Device-Device Incompatibility; Positioning Problem; Scratched Material; Device-Device Incompatibility; Positioning Problem; Scratched Material

  IT WAS REPORTED THAT THE BROACH HANDLE POST LEVERED WOULD NOT LOCK INTO BROACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8332405 ↗