Dynablator™ R-10005Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00859273007052), received between Sep 28, 2023 and Jul 8, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT OUTSIDE OF SURGERY WHEN DEVICE WAS TAKEN OUT OF LOAN TUB SMALL HOLES WERE NOTED IN THE PACKAGING IMPACTING STERILITY OF DEVICE. THERE WAS NO PATIENT INVOLVEMENT, AND PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22441281 ↗
• InjuryJul 8, 2025Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22436956 ↗
• InjurySep 24, 2024Fracture; Patient Device Interaction Problem; Fracture; Patient Device Interaction Problem

  IT WAS REPORTED THAT TOWARDS THE END OF AN ARTHROSCOPIC SHOULDER PROCEDURE, THE TIP OF THE DYNABLATOR HAD BROKEN OFF INSIDE THE PATIENT. SURGEON LOOKED INSIDE THE PATIENT FOR PIECE(S) THAT SEPARATED FROM DYNABLATOR, STAFF INSPECTED SUCTION CHANNEL AND LINE AND COULD NOT LOCATE IT/THEM. THERE WAS NO PATIENT HARM/INJURY REPORTED. THE MEDICAL PROFESSIONAL INDICATED THAT AN UNANTICIPATED SURGICAL COMPLICATION OCCURRED. THERE WAS A SURGICAL DELAY OF 30 MINUTES, AND THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20295253 ↗
• MalfunctionSep 28, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED DURING INCOMING INSPECTION AT DISTRIBUTOR WAREHOUSE PRODUCTS WERE FOUND TO BE NONCONFORMING. A CREASE IN THE STERILE SEAL. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17837908 ↗