INSTRUMENT 1020-5204Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327252620), received between Jun 19, 2017 and Apr 30, 2024 — classified as 6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2024Break; Break

  TRUNNION BROKE OF BROACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212439 ↗
• MalfunctionFeb 24, 2023Fracture; Material Deformation; Fracture; Material Deformation

  A SIZE 4 ACCOLADE 2 BROACH WAS PLACED IN THE FEMUR AND A CALCAR PLANER WAS USED. DURING THE PROCEDURE, A RASP HANDLE BECOME UNABLE TO ATTACH TO THE BROACH. THE RASP WAS PULLED OUT USING PLIERS. WHEN THE BROACH WAS LATER CHECKED, THE POST (PROTRUDING PART) WAS DAMAGED, WHICH LEADING FAILURE TO ATTACH THE RASP HANDLE TO IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16438038 ↗
• MalfunctionAug 17, 2022Fracture; Fracture

  BROACH CONNECTION TO BROACH HANDLE BROKE OFF IN THE HANDLE WHILE BROACHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15238690 ↗
• MalfunctionFeb 20, 2019Break; Break

  RUPTURE OF THE RASP HANDLE ON THE ACCOLADE II RASP # 4. SURGERY ON THE LEFT LEG. RASP COULD BE HARDLY REMOVED FROM FEMUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8353536 ↗
• MalfunctionJun 5, 2018Delamination; Delamination

  COLOR MARKING FROM THE RASPS CRUMBLE OFF. REPLACEMENT WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7569357 ↗
• MalfunctionJun 19, 2017Material Deformation; Scratched Material; Metal Shedding Debris; Material Deformation; Scratched Material

  COMPANY REPRESENTATIVE REPORTED THAT DURING THE USE OF THE CALCAR PLANNER ON THE BROACH, METALLIC FRAGMENTS WERE PRODUCED AND THEN WERE MANUALLY REMOVED FROM THE SURGICAL SITE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6652457 ↗