DYONICS SYNOVATOR 72203523Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885554027839), received between Jun 12, 2020 and Sep 11, 2022 — classified as 4 injuries, 2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE SURGEON OBSERVED THAT DEBRIS HAD COME FROM THE WORKING END OF THE SYNOVATOR SHAVER BLADE INTO THE JOINT; IT WAS STATED THE SHAVER BLADE WAS "UNDER NO PRESSURE". THE DEBRIS WAS REMOVED BY IRRIGATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15398014 ↗
• MalfunctionJun 13, 2021Corroded; Corroded

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THERE WAS RUST ON THE TIP OF THE SYNOVATOR PLATINUM BLADE. NO SIGNIFICANT DELAY AND PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11989120 ↗
• InjuryJan 18, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING SHOULDER SCOPE, THERE WAS SHEDDING METAL IN THE PATIENT, IT POP OUT FROM DISTAL TIP OF SHAVER. THE MALFUNCTION WAS SOLVED WITH NO SIGNIFICANT DELAYS OR PATIENT HARM USING A BACK UP DEVICE. 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 11189419 ↗
• InjuryJan 18, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING SHOULDER SCOPE, THERE WAS SHEDDING METAL IN THE PATIENT, IT POP OUT FROM DISTAL TIP OF SHAVER. THE MALFUNCTION WAS SOLVED WITH NO SIGNIFICANT DELAYS OR PATIENT HARM USING A BACK UP DEVICE. 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 11189418 ↗
• MalfunctionJan 6, 2021Corroded; Corroded

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE 4.5MM SYNOVATOR PLATINUM SERIES HAD RUST AT THE TIP OF THE BLADE. THE PRODUCT WAS NOT USED INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF 30 MINUTES OR LESS USING A SMITH AND NEPHEW 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11127825 ↗
• InjuryJun 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING KNEE PROCEDURE, THE SYNOVATOR PLATINUM BLADE WAS NOT WORKING, A BLACK RESIDUE WAS LEFT BEHIND WHILE USING. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY. NO 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: Injury

  MAUDE report 10149278 ↗