ShurFit MALIF System 23-9029-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840019925310), received between Jul 18, 2023 and Mar 31, 2026 — classified as 1 injury, 1 malfunction.

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

• MalfunctionMar 31, 2026Fracture

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2026. DURING USE, THE CUTTING HEAD PORTION OF THE PADDLE SHAVER 50MML X 10MMH (23-9029-03) BROKE OFF. THE TIP PIECE WAS EASILY REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR DELAY THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746828 ↗
• InjuryJul 18, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A LATERAL FUSION PROCEDURE WAS PERFORMED BY DR. DEBIPARSHAD, UTILIZING THE SHURFIT PLIF INTERBODY SYSTEM. WHILE USING THE PADDLE SHAVER 50MML X 10MMH (23-9029-03) TO OPEN THE DISC SPACE THE INSTRUMENT SNAPPED. THE SPACE WAS THEN OPENED WITH THE 8MM SHAVER TO RETRIEVE THE BROKEN PIECE. IT WAS CONFIRMED BY X-RAY THAT THE DISC SPACE WAS CLEAR OF ALL METAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ONLY A FIVE (5) MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343315 ↗