NA 72202531Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885554027891), received between Jan 30, 2018 and Mar 2, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Flaked” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING A PROCEDURE, SOME COVERING OF A FULL RADIUS BONE CUTTER LEFT A LOT OF DEBRIS. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OF IT THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480038 ↗
• MalfunctionNov 14, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE SIX(6) FULL RADIUS BONECUTTER BLADES OF THE SAME BOX PRODUCED A METALLIC POWDER. AS A RESULT, THE RESIDUAL METALLIC PARTICLES WERE LEFT IN THE PATIENT'S BODY, AND THE SURGEON REMOVED AS MUCH AS POSSIBLE. THE PROCEDURE WAS RESUMED, WITH A DELAY GREATER THAN 30 MINUTES, USING AN EQUIVALENT SN BACK-UP. ADDITIONAL ANESTHESIA WAS REQUIRED AS A CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556765 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE INNER BLADE OF THE FULL RADIUS BROKE IN TWO. THE PIECES STAYED INSIDE THE OUTER BLADE AND NOTHING FELL INTO THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22074771 ↗
• MalfunctionSep 9, 2021Break; Break

  IT WAS REPORTED THAT DURING SET UP OF AN ANKLE SCOPE SURGERY THE FULL RADIUS BONECUTTER 4.5MM PLATINUM WHILE THE TIP OF THE BLADE WAS ACTIVATED IT SHOWED A MALFUNCTION, THE BLADE WAS NOT FUNCTIONING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A FRACTURE DISTAL TIP WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12451588 ↗
• InjuryMay 31, 2021Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE SURGERY THE BONE CUTTER STARTED TO FALLING APART INSIDE THE PATIENT'S ANATOMY. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. UNKNOWN IF THERE WAS A DELAY. NO OTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11910781 ↗
• InjuryMay 14, 2021Flaked; Component Missing; Flaked; Component Missing

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BONECUTTER WAS RELEASING METAL SHAVINGS IN THE JOINT WHILE THE SHAVER WAS IN USE. IT WAS THEN NOTICED THAT THERE WAS A VISIBLE PATCH OF METAL MISSING FROM THE SHAVER ITSELF. THE PIECES WERE COMPLETELY RETRIEVED FROM THE PATIENT BY SUCTION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO DELAY AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11828437 ↗
• MalfunctionFeb 3, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE BLADE WAS DETACHING METAL PIECES AND PARTICLES WHEN THE DOCTOR WAS RESECTING THE TISSUE. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO SIGNIFICANT DELAY OR FURTHER COMPLICATIONS WERE REPORTED. 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 11273941 ↗
• MalfunctionSep 10, 2020Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING SETUP WHEN THE PACKAGE WAS OPEN SURGEON FOUND THAT THE TIP OF THE BONECUTTER WAS DIRTY. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO DELAY OR COMPLICATIONS WERE REPORTED. 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; No Patient Involvement

  MAUDE report 10514941 ↗
• MalfunctionJul 17, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING MENISCUS REPAIR SURGERY, WHEN THE DEVICE WAS BEING USED, THE SHAFT WAS BENT AND HEAT WAS GENERATED BY FRICTION CAUSING THE PATIENT TO BE BURNED AROUND THE PORTAL. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: Burn(s)

  MAUDE report 10293008 ↗
• MalfunctionNov 10, 2019Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY, THE BLADE BROKE INSIDE THE PATIENT AND IT STOPPED WORKING (IT ONLY WENT FORWARD, NOT IN REVERSE OR OSCILLATING). THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE 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 9302730 ↗
• MalfunctionNov 10, 2019Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY, THE BLADE BROKE INSIDE THE PATIENT AND IT STOPPED WORKING (IT ONLY WENT FORWARD, NOT IN REVERSE OR OSCILLATING). THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE 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 9302726 ↗
• MalfunctionJul 16, 2018Flaked

  IT WAS REPORTED THAT WHEN THE BLADE WAS ACTIVATED, METAL FLAKES SHED FROM THE INNER BLADE DURING PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER BLADE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7690207 ↗
• MalfunctionJan 30, 2018Metal Shedding Debris

  IT WAS RECORDED THAT THE FULL RADIUS BONECUTTER WAS PRESENTING SHEDDING ISSUES. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7229638 ↗