NA 214619Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705004027), received between Dec 27, 2019 and Jul 8, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionJul 8, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY, THE TIP OF A RASP DEVICE BROKE WHILE DETACHING TISSUE BETWEEN THE GLENOID CAVITY AND THE ROTATOR CUFF. ALL BROKEN FRAGMENTS OF THE RASP WERE REMOVED. THE SURGERY WAS COMPLETED WITHOUT DELAY OR PATIENT HARM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25753094 ↗
• MalfunctionApr 2, 2026Break

  IT WAS REPORTED THAT THE SHAFT PART OF THE ARTHRO RASP 20 UPBEND RASP DEVICE BROKE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24765290 ↗
• MalfunctionDec 27, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED FROM JAPAN BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE CUTTING DEVICE WAS USED TO REMOVE AN ARTICULAR LIP FROM A GLENOID, AND THE RASP TIP WAS DEFORMED AND COULD NOT BE USED FOR SURGERY. ANOTHER RASP WAS USED IN THE SAME WAY, AND IT WAS ALSO DEFORMED. WHEN THE SURGEON ATTEMPTED TO PUT IT BACK ON THE OPERATING TABLE, THE RASP IN QUESTION BROKE OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18401923 ↗
• MalfunctionApr 5, 2023Material Deformation; Material Deformation

  THIS IS REPORT 1 OF 4 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE RASP - 20 DEGREES UP BEND DEVICE WAS BENT. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685686 ↗
• MalfunctionNov 9, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE UP LIBERATOR RASP 20° UP BEND WAS CLEARLY BENT WHEN THE LOAN TRAY WAS OPENED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15763967 ↗
• MalfunctionMay 4, 2022Material Deformation; Material Deformation

  THIS IS REPORT 2 OF 2 IN (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE RASP 20° UP BEND WAS BENT. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14278942 ↗
• MalfunctionApr 20, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE TIP ON THE BONE RASP DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11695348 ↗
• MalfunctionDec 27, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY AFFILIATE VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE SURGEON NOTICED THAT RASP SHAFT OF A RASP 20° UP BEND, WAS BENT. THE SURGERY WAS COMPLETED BY USING THE SAME BENT INSTRUMENT. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9526886 ↗