NA 899710032Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207038154), received between Jun 23, 2022 and Aug 29, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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.

• MalfunctionAug 29, 2022Material Fragmentation; Material Fragmentation

  RICHARD WOLF GMBH COMPLAINT REFERENCE (B)(4). THE USER INFORMED RICHARD WOLF THAT THE TIP OF THE SHAVERBLADE BROKE OFF INTRAOPERATIVELY. THE BROKEN TIP WAS RECOVERED. THIS RESULTED IN AN EXTENSION OF THE SURGERY TIME BY 45 MINUTES. THE APPLICATION WAS COMPLETED WITH ANOTHER SHAVER. RWGMBH AWARENESS DATE, (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15314829 ↗
• MalfunctionJun 23, 2022Material Fragmentation; Material Fragmentation

  DURING WRIST ARTHROSCOPY, THE SHAVER (INNER KNIFE) BROKE OFF DISTALLY IN THE AREA OF THE WRIST CAPSULE. UNDER X-RAY CONTROL, THE BROKEN PIECE WAS REMOVED. ACCORDING TO THE ATTENDING SURGEON, THIS REQUIRED AN ADDITIONAL 45-60 MINUTES.

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

  MAUDE report 14787266 ↗