NA 7206011Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010440242), received between Nov 23, 2018 and May 15, 2024 — classified as 6 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE BLADE OUTER SHAFT SEPARATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323779 ↗
• InjuryJun 16, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BONECUTTER BLADE STOPPED ASPIRATING WHEN IT WAS VERIFIED THAT THE TIP OF THE INNER CANNULA WAS BROKEN. THE PROCEDURE WAS SUCCESSFULLY WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE CURRENT STATUS OF THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14724530 ↗
• InjuryAug 9, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, A PART OF THE TIP OF THE INNER BONECUTTER BLADE WAS PEELED OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. IT IS UNKNOWN IF THE PEEL PART WAS REMOVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12297770 ↗
• InjuryApr 28, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING A SHOULDER ARTHOSCOPY THE BONE CUTTER BLADE APPEARED TO HAVE SOME METAL POWDER DETACHED FROM THE SHAVER WHEN BURRING. THE PROCEDURE WAS COMPLETED WITH A 30 MINUTES OR LESS DELAY. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11741334 ↗
• InjuryApr 28, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE BONE CUTTER BLADE APPEARED TO HAVE SOME METAL POWDER DETACHED FROM THE SHAVER WHEN BURRING. THE PROCEDURE WAS COMPLETED WITH A 30 MINUTES OR LESS DELAY. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11741307 ↗
• MalfunctionFeb 19, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT, DURING SET UP FOR SURGERY, WHEN THE PACKAGE WAS OPENED, THE SURGEON FOUND THAT THE TIP OF THE "4.5MM FULL RADIUS DISPOSABLE BLADES" WAS DIRTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11349113 ↗
• InjuryFeb 19, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT, DURING SET UP FOR SURGERY, WHEN THE PACKAGE WAS OPENED, THE SURGEON FOUND THAT THE TIP OF THE "4.5MM FULL RADIUS DISPOSABLE BLADES" WAS DIRTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11349111 ↗
• MalfunctionDec 11, 2020Corroded; Corroded

  IT WAS REPORTED THAT THE TIP OF THE 4.5 MM FULL RADIUS BONECUTTER WAS RUSTED. THIS WAS NOTICED DURING SET UP OF THE SHOULDER ARTHROSCOPY PROCEDURE; THEREFORE, THE DEVICE WAS NOT USED IN THE PATIENT. A BACKUP DEVICE WAS AVAILABLE AND NO SIGNIFICANT DELAY WAS 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 10991431 ↗
• InjuryAug 12, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY SURGERY, THE SHAVER TIP WAS OVERHEATED AND BURNED THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 8883845 ↗
• MalfunctionAug 12, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY SURGERY, THE SHAVER TIP BROKE INSIDE THE PATIENT. THE PIECES WERE REMOVED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8883822 ↗
• MalfunctionJan 15, 2019Peeled/Delaminated

  IT WAS REPORTED THAT SHAVINGS PEELING OFF RIGHT AT THE START OF THE CASE BEFORE ANY RESECTION IS EVEN STARTED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8248806 ↗
• MalfunctionDec 10, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT METAL FLAKES WERE SHED FROM THE BLADE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES REPORTED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8148568 ↗
• MalfunctionNov 23, 2018Material Fragmentation; Failure to Cut

  IT WAS REPORTED THAT THE BONECUTTER BLADE PRODUCED SMALL CHIPS OF METAL IN THE JOINT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100077 ↗