NA 72203128Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010655332), received between Jan 15, 2024 and Jan 15, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2024Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE TIP OF THE BURR 4.0 ABRADER BROKE AND FELL INSIDE THE PATIENT. SOME OF THE PIECES WERE REMOVED USING GRASPERS, HOWEVER SMALL AMOUNTS WERE LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18510722 ↗
• InjuryJan 15, 2024Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE TIP OF THE BURR 4.0 ABRADER BROKE AND FELL INSIDE THE PATIENT. SOME OF THE PIECES WERE REMOVED USING GRASPERS AND SMALL AMOUNTS WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18510659 ↗