FMS 283858Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705025107), received between Jan 30, 2019 and Jun 29, 2020 — classified as 2 malfunctions.

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

• MalfunctionJun 29, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY SALES REP THAT DURING A HIP SCOPE WHEN A 5.0MM XL ROUND BURR PLUS WAS OPENED BEFORE IT COULD BE USED, IT WAS NOTICED THAT THE BLADE INSIDE OF THE SHAVER SHEATH WOULD NOT ROTATE. IT APPEARED TO BE STUCK AND DEEMED UNUSABLE. PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10206905 ↗
• MalfunctionJan 30, 2019Break; Break

  IT WAS REPORT THAT DURING A HIP ARTHROSCOPY PROCEDURE THE SURGEON WAS TORQUING ON A 5.0MM XL ROUND BURR WHEN THE PLASTIC JUNCTION BROKE WHERE IT INSERTS INTO THE HAND PIECE. IT WAS STATED THAT NOTHING FELL INTO THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES AND A DELAY OF A COUPLE OF MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8290872 ↗