NA 7205324Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010251527), received between May 13, 2019 and Jan 13, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Flaked” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Flaked

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT THERE WERE IRON WIRES AT THE GRINDING AREA OF THE ABRADER BLADE, AND THE POLISHING WAS NOT DONE THOROUGHLY, AND COULD NOT BE USE. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054997 ↗
• MalfunctionDec 22, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A RIGHT ELBOW PROCEDURE, SOME PLASTIC PARTS OF THE ABRADER BLADE MELTED AND FELL OFF. THE PROCEDURE WAS COMPLETED USING A SN EQUIVALENT DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864749 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT, DURING A RECONSTRUCTION OF LOWER LIMB MUSCLE FLEXION SURGERY, THE HEAD OF ONE (1) ABRADER BLADE WAS BROKEN AND COULD NOT BE USED. THE PROCEDURE WAS PERFORMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23573130 ↗
• MalfunctionNov 17, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT BEFORE A KNEE ARTHROSCOPY, IT WAS NOTICED THAT THE PACKAGING OF AN ABRADER DISPOSABLE BLADE WAS BROKEN AND THEREFORE IT WAS NOT USED. THE PROCEDURE WAS PERFORMED WITHOUT ANY SURGICAL DELAY USING AN EQUIVALENT S+N BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED, AND THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566654 ↗
• MalfunctionOct 15, 2023Flaked; Material Integrity Problem; Flaked; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, AFTER OPENING THE ABRADER BLADE PACKAGE, METAL CHIPS FELL FROM IT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE, BUT IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17937101 ↗
• MalfunctionJan 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE THE ABRADER OUTER SHEATH OF THE BLADE SUDDENLY CAME OUT AND SEPARATED. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183893 ↗
• MalfunctionFeb 22, 2021Overheating of Device; Material Separation; Material Deformation; Overheating of Device; Material Separation; Material Deformation

  IT WAS REPORTED THAT DURING THE SURGERY, IN LESS THAN ONE MINUTE AFTER THE BLADE WAS USED THE COLLOID MELTED AT THE INTERFACE BETWEEN THE BLADE AND THE WIRE. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THERE WAS DEBRIS ON THE INNER BLADE, WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11359483 ↗
• MalfunctionMar 20, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PROCEDURE BLADE BROKE INSIDE THE PATIENT HOWEVER IT IS UNKNOWN IF PIECES WERE RETRIEVED AND HOW. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED SINCE NO BACK UP WAS AVAILABLE. NO PATIENT INJURIES OR DELAY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9861304 ↗
• MalfunctionSep 20, 2019Melted; Melted

  IT WAS REPORTED THAT DURING THE SURGERY, WHEN USING THE BLADE OF THE SHAVER IT STOPPED WORKING AND THE PART THAT FITS IN THE HANDPIECE WAS MELTED. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INJURY REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE DEVICE MELTED DUE TO AN OVERHEATING WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9097913 ↗
• MalfunctionAug 21, 2019Flaked; Flaked

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE DEVICE WAS USED TO SHAVE THE GLENOID CAVITY, IT MADE THE METAL FLAKE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE WITH NO DELAY OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8915027 ↗
• MalfunctionMay 13, 2019Material Fragmentation; Noise, Audible

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADE MADE A METALLIC NOISE WHEN ROTATING AND THE METAL FLAKES WERE SHED FROM THE BLADE. EVEN THOUGH THE COMPLAINANT CONFIRMED THAT THE METAL FLAKES FELL OFF OUTSIDE THE BODY, SHE SAID THAT THIS BLADE HAD BEEN USED IN PATIENT. THERE WERE NO SURGICAL DELAY OR PATIENT INJURIES. NO BACKUP DEVICE WAS AVAILABLE AND ACCORDING WITH THE REPORTER, IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8603113 ↗