NA 72201519Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010621641), received between Aug 15, 2018 and Nov 17, 2025 — classified as 2 injuries, 4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, DURING AN ARTHRODESIS OF THE ANKLE PROCEDURE, THE ABRADER BLADE WAS BROKEN. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS RESUMED AFTER A 10-MINUTE SURGICAL DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569485 ↗
• MalfunctionOct 23, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE INNER BLADE OF THE ABRADER 3.5 WAS BROKEN. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF 15 MINUTES. IT IS UNKNOWN IF THERE WAS A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517177 ↗
• InjuryOct 11, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE INNER BLADE OF THE 3.5MM ABRADER BROKE. ALL THE PIECES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581738 ↗
• InjuryJun 11, 2021Break; Break

  IT WAS REPORTED THAT THE DURING ANKLE ARTHROSCOPIC PROCEDURE, INSIDE THE PATIENT, THE ABRADER 3.5 MAG-MINI DISP. BLADE WAS BROKEN WHEN SHAVING THE TALUS SUBCHONDRAL BONE. THE PROCEDURE WAS FINISHED WITH A SMIT AND NEPHEW BACKUP DEVICE. 10 MINUTES DELAY, NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987634 ↗
• MalfunctionJan 22, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE FOR RESECTION OF BONE SPURS, THE TIP OF THE BLADE WERE CAME OUT. THE PIECE WAS REMOVED. NO PATIENT INJURIES AND COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8267323 ↗
• MalfunctionAug 15, 2018Material Fragmentation; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT PIECES OF METAL WERE FLYING OFF OF THEM WHILE BEING USED IN A CASE. THE PIECES FELT OFF INTO THE PATIENT'S ANATOMY, ALL THE PIECES WERE REMOVED FROM THE PATIENT. BACK-UP DEVICE WAS AVAILABLE. AS PER CUSTOMER RESPONSE THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7787277 ↗