DYONICS 72203131Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885554025514), received between Jun 4, 2021 and Jun 7, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Fragmentation” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING USE THE BURR 5.5MM BARREL 180MM LONG HIGH VIS SYSTEMATICALLY RELEASED METAL INTO THE PATIENT. THE METAL DEBRIS WAS CLEANED UP. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY AND AN UNKNOWN PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11950025 ↗
• InjuryJun 7, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING USE THE BURR 5.5MM BARREL 180MM LONG HIGH VIS SYSTEMATICALLY RELEASED METAL INTO THE PATIENT. THE METAL DEBRIS WAS CLEANED UP. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY AND AN UNKNOWN PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11948572 ↗
• InjuryJun 4, 2021Flaked; Material Fragmentation; Flaked; Material Fragmentation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE BURR SHEATH SYSTEMATICALLY RELEASED METAL INTO THE PATIENT. THE METAL DEBRIS WAS CLEANED UP FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. A SIGNIFICANT DELAY AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11943454 ↗
• InjuryJun 4, 2021Flaked; Material Fragmentation; Flaked; Material Fragmentation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE BURR SHEATH SYSTEMATICALLY RELEASED METAL INTO THE PATIENT. THE METAL DEBRIS WAS CLEANED UP FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. A SIGNIFICANT DELAY AND NO OTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 11943069 ↗