DYONICS 7205306Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010251343), received between Jun 24, 2019 and Dec 29, 2023 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, DURING THE CLEANING OF SYNOVIAL TISSUE, THE INNER CORE OF THE FULL RADIUS BLADE WAS CRACKED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419426 ↗
• MalfunctionNov 16, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, IT WAS NOTICED THAT THE INNER FULL RADIUS BLADE WAS NOT OSCILLATING; IT WAS WORKING WELL, BUT A FEW SECONDS LATER IT STOPPED WHEN THE BREAK WAS NOTICED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION FOUND IT IS FRACTURED AT/BELOW ONE OF THE HEAVILY DEGRADED AREAS AND THAT THERE ARE METAL FRAGMENTS STUCK TO THE INNER SLUFF CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149954 ↗
• InjuryDec 22, 2022Break; Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE, THE 4.5MM FULL RADIUS BLADE WAS USED TO CLEAN THE SYNOVIAL TISSUE AND IT BROKE. THE PIECES WERE REMOVED FROM THE PATIENT USING A GRASPER. THE SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16034560 ↗
• InjuryNov 15, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE SHAVER BLADE RELEASED A KIND OF DIRT IN THE PATIENTS JOINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12817767 ↗
• InjuryJul 13, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A SYNOVECTOMY THE FULL RADIUS BLADE HAD A FAILURE, THE SYNOVIUM TEARS UP, IT CAUSED BLEEDING AND IT WAS RELIEVED AFTER USING HEMOSTASIS WITH RADIOFREQUENCY. PATIENT HAS BEEN RECOVERED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 12158353 ↗
• InjuryJun 9, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY WHEN THE DOCTOR WAS USING THE SHAVER THE TWO PIECES OF METAL IN THE SHAVER BLADE (FULL RADIUS BL) WERE COMING IN CONTACT WITH EACH OTHER AND CREATING A BLACK RESIDUE THAT WAS BEING TRANSFERRED TO THE PATIENTS TISSUE. SOON AFTER THE BLACK RESIDUE WAS OBSERVED, THE DOCTOR STOPPED USING THAT SHAVER BLADE AND REPLACED IT WITH ANOTHER OF A DIFFERENT LOT NUMBER AND CONTINUED THE SURGERY WITHOUT INCIDENT. SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES. NO FURTHER COMPLICATIONS TO PATIENT WERE REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11965143 ↗
• InjuryMay 7, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING USE INSIDE THE PATIENT, THE SHAVER WAS SHEDDING METAL SHAVINGS INTO THE JOINT. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795020 ↗
• InjuryAug 18, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PROCEDURE THE FULL RADIUS BLADE SHAVER PIECE BROKE INSIDE THE PATIENT'S KNEE. NO DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. 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: No Information

  MAUDE report 10423602 ↗
• MalfunctionJun 24, 2019Material Discolored; Material Discolored

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, IT WAS NOTICED THAT THE TIP OF THE BLADE WAS BLACK. THERE WAS NO DELAY OR PATIENT INJURIES BUT, IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED SINCE NO BACKUP DEVICE WAS AVAILABLE TO COMPLETE IT. ATTEMPTS WERE MADE TO RETRIEVE FURTHER DETAILS ABOUT THE EVENT BUT THE COMPLAINANT DOES NOT HAVE MORE INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8726465 ↗