NA 899750033Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207038253), received between Oct 31, 2019 and Oct 31, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2019Material Fragmentation; Material Fragmentation

  ON SEPTEMBER 05, 2019, RICHARD WOLF (B)(4) RECEIVED THE FOLLOWING INFORMATION: IN THE COURSE OF A KNEE ARTHROSCOPY, THE INNER PART OF THE SHAVER BROKE. DURING SHAVING IN THE NOTCH AREA OF THE HOFFA'S (INFRAPATELLAR) FAT PAD (HFP), THE SHAVER MALFUNCTIONED AND INSPECTION OF THE BLADE REVEALED THAT THE TIP HAD BROKEN OFF. THE FRAGMENT COULD NOT BE RECOVERED ARTHROSCOPICALLY AND REMAINED IN THE PATIENT. X-RAY CONTROL EXAMINATIONS WERE CARRIED OUT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9263620 ↗